Optical pulse-width modulation used in an optical-stimulation cochlear implant

ABSTRACT

Method and apparatus for optically stimulating neurons of a plurality of auditory nerve pathways of a person to provide auditory sensations for the person including generating a plurality of pulsed light signals having one or more successive pulses; delivering the plurality of pulsed light signals to one or more auditory nerve pathways of the cochlea of the person; selectively controlling the plurality of light signals to optically stimulate and trigger nerve action potentials (NAPs) in the one or more auditory nerve pathways. In some embodiments of the present invention, pulse-repetition rate and peak pulse power are held constant, while pulse width is modulated to evoke a sufficient dynamic range of NAPs (i.e., different NAP strengths), thus encoding sound-loudness information for the listener.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority benefit, under 35 U.S.C. §119(e), of

U.S. Provisional Patent Application No. 61/511,020 filed Jul. 22, 2011by Ryan C. Stafford, titled “Method and Apparatus for Optimizing anOptically Stimulating Cochlear Implant” (Attorney Docket 5032.071PV1);U.S. Provisional Patent Application No. 61/511,048 filed Jul. 23, 2011by Ryan C. Stafford, titled “Broad Wavelength Profile to Homogenize theAbsorption Profile in Optical Stimulation of the Cochlea” (AttorneyDocket 5032.072PV1); andU.S. Provisional Patent Application No. 61/511,050 filed Jul. 23, 2011by Ryan C. Stafford et al., titled “Optical Cochlear Implant withElectrode(s) at the Apical End for Stimulation of Apical Spiral GanglionCells of the Cochlea” (Attorney Docket 5032.073PV1); each of which isincorporated herein by reference in its entirety.

This invention is related to:

U.S. patent application Ser. No. ______ filed on even date herewith byRyan C. Stafford et al. and titled “OPTICAL-STIMULATION COCHLEAR IMPLANTWITH ELECTRODE(S) AT THE APICAL END FOR ELECTRICAL STIMULATION OF APICALSPIRAL GANGLION CELLS OF THE COCHLEA” (Attorney Docket 5032.071US1),

U.S. patent application Ser. No. ______ filed on even date herewith byRyan C. Stafford and titled “BROAD WAVELENGTH PROFILE TO HOMOGENIZE THEABSORPTION PROFILE IN OPTICAL STIMULATION OF NERVES” (Attorney Docket5032.072US1),

U.S. patent application Ser. No. ______ filed on even date herewith byRyan C. Stafford et al. and titled “INDIVIDUALLY OPTIMIZED PERFORMANCEOF OPTICALLY STIMULATING COCHLEAR IMPLANTS” (Attorney Docket5032.073US1),

U.S. patent application Ser. No. ______ filed on even date herewith byRyan C. Stafford et al. and titled “COCHLEAR IMPLANT AND METHOD ENABLINGENHANCED MUSIC PERCEPTION” (Attorney Docket 5032.077US1),

U.S. patent application Ser. No. ______ filed on even date herewith byRyan C. Stafford et al. and titled “COCHLEAR IMPLANT USING OPTICALSTIMULATION WITH ENCODED INFORMATION DESIGNED TO LIMIT HEATING EFFECTS”(Attorney Docket 5032.078US1),

U.S. patent application Ser. No. ______ filed on even date herewith byRyan C. Stafford et al. and titled “OPTICAL PULSE-WIDTH MODULATION USEDIN AN OPTICAL-STIMULATION COCHLEAR IMPLANT” (Attorney Docket5032.079US1), and

U.S. patent application Ser. No. ______ filed on even date herewith byRyan C. Stafford et al. and titled “OPTIMIZED STIMULATION RATE OF ANOPTICALLY STIMULATING COCHLEAR IMPLANT” (Attorney Docket 5032.080US1),each of which is incorporated herein by reference in its entirety.

This invention is also related to:

U.S. Pat. No. 7,736,382 titled “Apparatus for Optical Stimulation ofNerves and other Animal Tissue” that issued Jun. 15, 2010 to James S.Webb et al. (Attorney Docket 5032.009US1),

U.S. Pat. No. 7,988,688 titled “Miniature Apparatus and Method forOptical Stimulation of Nerves and other Animal Tissue” that issued Aug.2, 2011 to James S. Webb et al. (Attorney Docket 5032.020US1),

U.S. patent application Ser. No. 11/948,912 filed Nov. 30, 2007 by JamesS. Webb et al., titled “Apparatus and Method for Characterizing OpticalSources used with Human and Animal Tissues” (Attorney Docket5032.022US1),

U.S. Patent Application Publication US 2008/0077200 of Mark P. Bendettet al., dated Mar. 27, 2008 and titled “Apparatus and Method forStimulation of Nerves and Automated Control of Surgical Instruments”(Attorney Docket 5032.023US1),

U.S. Pat. No. 8,012,189 titled “Vestibular Implant using OpticalStimulation of Nerves” that issued Sep. 6, 2011 to James S. Webb et al.(Attorney Docket 5032.026US1),

U.S. Pat. No. 7,883,536 titled “Hybrid Optical-Electrical Probes” thatissued Feb. 8, 2011 to Mark P. Bendett et al. (Attorney Docket5032.027US1),

U.S. patent application Ser. No. 12/191,301 filed Aug. 13, 2008 by MarkP. Bendett et al., titled “VCSEL Array Stimulator Apparatus and Methodfor Light Stimulation of Bodily Tissues” (Attorney Docket 5032.038US1),

U.S. Patent Application Publication US 2010/0049180 of Jonathon D. Wellset al., dated Feb. 25, 2010 and titled “System and Method forConditioning Animal Tissue Using Laser Light” (Attorney Docket5032.039US1),

U.S. Pat. No. 8,160,696 titled “Nerve Stimulator and Method usingSimultaneous Electrical and Optical Signals” that issued Apr. 17, 2012to Mark P. Bendett et al. (Attorney Docket 5032.045US1),

U.S. Patent Application Publication US 2011/0172725 of Jonathon D. Wellset al., dated Jul. 14, 2011 and titled “Nerve Stimulator and Methodusing Simultaneous Electrical and Optical Signals” (Attorney Docket5032.045US2),

U.S. Patent Application Publication US 2010/0292758 of Daniel J. Lee etal., dated Nov. 18, 2010 and titled “Optical Stimulation of theBrainstem and/or Midbrain, Including Auditory Areas” (Attorney Docket5032.046US1),

U.S. Patent Application Publication US 2011/0295331 of Jonathon D. Wellset al., dated Dec. 1, 2011 and titled “Laser-Based Nerve Stimulatorsfor, e.g., Hearing Restoration in Cochlear Prostheses” (Attorney Docket5032.063US1),

U.S. Patent Application Publication US 2011/0295345 of Jonathon D. Wellset al., dated Dec. 1, 2011 and titled “Implantable Infrared NerveStimulation Devices for Peripheral and Cranial Nerve Interfaces”(Attorney Docket 5032.064US1),

U.S. Patent Application Publication US 2011/0295346 of Jonathon D. Wellset al., dated Dec. 1, 2011 and titled “Cuff Apparatus and Method forOptical and/or Electrical Nerve Stimulation of Peripheral Nerves”(Attorney Docket 5032.064US2),

U.S. Patent Application Publication US 2011/0295347 of Jonathon D. Wellset al., dated Dec. 1, 2011 and titled “Nerve-Penetrating Apparatus andMethod for Optical and/or Electrical Nerve Stimulation of PeripheralNerves” (Attorney Docket 5032.064US3),

U.S. Patent Application Publication US 2011/0295344 of Jonathon D. Wellset al., dated Dec. 1, 2011 and titled “Optical Bundle Apparatus andMethod For Optical and/or Electrical Nerve Stimulation of PeripheralNerves” (Attorney Docket 5032.064US4),

U.S. Provisional Patent Application 61/349,810 filed May 28, 2010 byJonathon D. Wells et al., titled “Implantable Infrared Nerve StimulationDevices for Peripheral and Cranial Nerve Interfaces” (Attorney Docket5032.064PV1), and

U.S. Provisional Patent Application 61/386,461 filed Sep. 24, 2010 byJonathon D. Wells et al., titled “Implantable Infrared Nerve StimulationDevices for Peripheral and Cranial Nerve Interfaces” (Attorney Docket5032.064PV2), each of which is incorporated herein by reference in itsentirety including all appendices.

FIELD OF THE INVENTION

The invention relates generally to optical stimulation of nerves torestore hearing, and more particularly to apparatus and methods forusing pulse width modulation of the optical stimulation signals toencode sound loudness information to the listener.

BACKGROUND OF THE INVENTION

The commercialization of cochlear implants, which directly stimulate theauditory nerve to provide hearing to the profoundly deaf, is somewhatrecent (introduced in 1984 as an FDA-approved device). Theseconventional devices utilize the compound nerve action potential (CNAP)produced by the presence of an electric field in proximity of the spiralganglion cells within the cochlea. In such conventional devices,acoustic sounds from the environment are digitized, separated into aplurality of frequency bands (called “audio-frequency channels” herein)and the loudness envelope of the signal in all of the audio-frequencychannels carries the information necessary to generate electricalsignals to stimulate cochlear nerves to allow the patient to perceivespeech and other pertinent sounds. In electrical cochlear implants,pulsatile electric currents are modulated in amplitude to convey thisinformation to the listener. Pulse-repetition rate and pulse width wouldtypically be held constant, while pulse amplitude is modulated to followrelative changes in loudness. While electrical cochlear implants can beeffective, they often lack the specificity to target the desiredauditory nerve pathway without also activating other auditory nervepathways as a side effect (because electrical current spreads in thebody, most if not all neuromodulation devices wind up stimulating othernerves in the area besides the intended target (thus potentiallycausing, for example, unintended hearing sensations)). The presence of astimulation artifact can also obfuscate signals elsewhere along theauditory nerve, which precludes stimulating and recording electricalnerve activity in the same location.

As used herein, the auditory-nerve pathway includes all of the nervesfrom and including the cochlea, to and including the brain stem.

The discovery that neural compound action potentials (CAPs) can beevoked by pulsed optical stimulation has led to development of cochlearimplants based on optical stimulation (e.g., see U.S. Pat. No. 8,012,189issued Sep. 6, 2011 to James S. Webb et al., titled “Vestibular Implantusing Optical Stimulation Of Nerves” (Attorney Docket 5032.026US1), andU.S. Patent Application Publication US 2011/0295331 of Jonathon D. Wellset al., dated Dec. 1, 2011 and titled “Laser-Based Nerve Stimulatorsfor, e.g., Hearing Restoration in Cochlear Prostheses” (Attorney Docket5032.063US1), both of which are incorporated herein by reference, andboth of which are assigned to Lockheed Martin Corporation, the assigneeof the present invention). Optical stimulation provides more preciseneural stimulation compared to electrical stimulation methods becauselight is directed in a single direction, and there is no stimulationartifact. However, the physiological mechanism of optical stimulation isdifferent than that of electrical stimulation. This leads to thechallenge of encoding the information for the listener in a way thatoptimally exploits the physiological mechanism of optical stimulation.

U.S. Patent Application Publication US 2010/0049180 of Jonathon D. Wellset al., dated Feb. 25, 2010 and titled “System and Method forConditioning Animal Tissue using Laser Light” (Attorney Docket5032.039US1), is incorporated herein by reference in its entirety. Wellset al. describe systems and methods for prophylactic measures aimed atimproving wound repair. In some embodiments, laser-mediatedpreconditioning would enhance surgical wound healing that was correlatedwith hsp70 expression. Using a pulsed laser (λ=1850 nm, Tp=2 ms, 50 Hz(in this context, Hz means stimulation pulses per second (pps)), H=7.64mJ/cm²) the skin of transgenic mice that contain an hsp70promoter-driven luciferase were preconditioned 12 hours before surgicalincisions were made. Laser protocols were optimized using temperature,blood flow, and hsp70-mediated bioluminescence measurements asbenchmarks. Bioluminescent imaging studies in vivo indicated that anoptimized laser protocol increased hsp70 expression by 15-fold. Underthese conditions, healed areas from incisions that werelaser-preconditioned were two times stronger than those from controlwounds. Though useful for wound treatment and surgical pre-treating,chronic heating of tissue (such as the cochlea) is detrimental.

Other prior-art includes:

Qian-Jie Fu and Robert Shannon, “Effect of Stimulation Rate on PhonemeRecognition by Nucleus-22 Cochlear Implant Listeners,” J. Acoust. Soc.Am., vol. 107, pp 589-597 (1999) (hereinafter Fu et al., 1999);

Kandel, “Principles of Neural Science”, McGraw-Hill Medical; 4^(th)edition (January 2000), Ch 30-31 (hereinafter Kandel, 2000);

Loizou, “Speech Processing in Vocoder-Centric Cochlear Implants,” Adv.Oto-Rhino-Laryngology, vol. 64, pp 109-143, Karger, (2006) (hereinafterLoizou, 2006);

Vandali, “Speech Perception as a Function of Electrical StimulationRate: Using the Nucleus 24 Cochlear Implant System,” Ear and Hearing,vol. 21, pp 608-624, (December 2000) (hereinafter Vandali, 2000);

McKay, “Loudness Summation for Pulsatile Electrical Stimulation of theCochlea: Effects of Rate, Electrode Separation, Level, and Mode ofStimulation,” J. Acoust. Soc. Am., vol. 110, pp 1514-24 (September 2001)(hereinafter McKay, 2001);

McKay, “Loudness Perception with Pulsatile Electrical Stimulation: TheEffect of Interpulse Intervals,” J. Acoust. Soc. Am., vol. 104, pp1061-74 (1998) (hereinafter McKay, 1998);

Littlefield, “Laser Stimulation of Single Auditory Nerve Fibers,”Laryngoscope, vol. 120, pp 2071-82, (2010) (hereinafter Littlefield,2010);

Heinz, “Response Growth with Sound Level in Auditory-Nerve Fibers AfterNoise-Induced Hearing Loss,” J. Neurophysiology, vol. 91, pp 784-95(2004);

Fu & Shannon, “Effects of Dynamic Range and Amplitude Mapping on PhonemeRecognition in Nucleus-22 Cochlear Implant Users,” Ear and Hearing, vol.21, pp 227-235 (2000) (hereinafter Fu et al., 2000);

Nelson, “Intensity Discrimination as a Function of Stimulus Level withElectric Stimulation,” J. Acoust. Soc. Am., vol. 100, pp 2393-2414(October 1996) (hereinafter Nelson, 1996);

Omran, “Semitone Frequency Mapping to Improve Music Representation forNucleus Cochlear Implants,” EURASIP Journal on Audio, Speech, and MusicProcessing, 2011:2 (2011) (hereinafter Omran, 2011); and

Fischer, “Plano Tuning,” Theodore Presser Co. (1907) (reprinted by DoverPublications, 1975) (hereinafter Fischer, 1907/1975); each of which isincorporated herein by reference.

There is a need for an improved apparatus and a corresponding method foroptical (and optionally optical combined with electrical) stimulation ofnerves to restore hearing.

BRIEF SUMMARY OF THE INVENTION

In some embodiments, the present invention provides an apparatus thatincludes an infrared (IR) light source. The IR light provides opticalstimulation of nerves to generate nerve-action potentials (NAPs) in oneor more individual nerve cells, and/or compound nerve-action potentials(CNAPs) in a nerve bundle. In some embodiments, the stimulation of NAPsand CNAPs is used to restore hearing.

In some embodiments, the present invention provides an apparatus andmethod in which pulse-width modulation is applied to theoptical-stimulation pulses to the cochlea nerves, via a cochlearimplant, to obtain an increased dynamic range (a variation in theloudness perceived by the patient). Experiments [Izzo 2006] have shownthat neural compound nerve-action potentials (CNAPs, also called CAPs)can be evoked by pulsed optical stimulation and the magnitude of theaction potential is a function of the peak power of the incident pulsesfor pulses shorter than about 100 microseconds (μs). As pulses areshortened and peak power is held constant, the CAP reduces. This effectcan be utilized to encode loudness information, since the CAP leveldetermines perceived loudness.

In some embodiments of the present invention, pulse-repetition rate andpeak pulse power are held constant, while pulse width is modulated toevoke a sufficient dynamic range of CAPs (i.e., different CAPstrengths), thus encoding sound-loudness information for the listener.An advantage of this method of encoding is the CAP can be very sensitiveto pulse width in this regime, and therefore optical-pulse width is auseful parameter to vary, and this achieves a large range of stimulationfor a small change in pulse width. In some embodiment, the pulse widthis adjusted to be optimized for the individual during successivesystem-tuning sessions after implantation.

The present invention provides greater dynamic range of loudness asperceived the wearer of the cochlear implant than is available fromelectrical stimulation cochlear implants.

BRIEF DESCRIPTION OF THE FIGURES

Each of the items shown in the figures described in the following briefdescription of the drawings represents some embodiments of the presentinvention.

FIG. 1 is a schematic representation of a system 100 with a hardware-and operating-environment having an implanted device 110, an optionalexternally worn device 111 and a customization console computer 20.

FIG. 2A is a schematic diagram illustrating an implantedcochlea-stimulation device 200.

FIG. 2B is a schematic cutaway diagram illustrating an implantedcochlea-stimulation device 200 implanted such that a portion of device200 is coiled within the cochlea 85.

FIG. 2C is a schematic perspective exploded-view diagram illustratingVCSEL array and focussing device 205, used for some embodiments of VCSELemitters 244 of FIG. 2B.

FIG. 3A is a schematic diagram of a broadband wavelength source 310having a designed power/wavelength spectrum profile formed to customizethe absorption of optical power in the tissue of interest.

FIG. 3B includes a schematic graph 307A of a tissue sensitivity tooptical stimulation for a first given type or composition of tissue as afunction of the wavelength of the optical stimulation.

FIG. 3C is a schematic diagram of a broadband wavelength source 320having a designed power/wavelength spectrum profile formed to customizethe absorption of optical power in the tissue of interest.

FIG. 3D is a schematic graph 308A of a designed power/wavelengthspectrum profile used to customize the absorption of optical power inthe tissue.

FIG. 3E is a schematic diagram of a broadband wavelength source 330having a designed power/wavelength spectrum profile formed to customizethe absorption of optical power in the tissue of interest.

FIG. 3F is a schematic graph 309A of a designed power/wavelengthspectrum profile used to customize the absorption of optical power inthe tissue.

FIG. 3G is a schematic graph 307B of a tissue sensitivity to opticalstimulation for a second given type or composition of tissue as afunction of the wavelength of the optical stimulation.

FIG. 3H is a schematic graph 308B of a designed power/wavelengthspectrum profile used to customize the absorption of optical power inthe tissue.

FIG. 3I is a schematic graph 309B of a designed power/wavelengthspectrum profile used to customize the absorption of optical power inthe tissue.

FIG. 3J includes schematic graphs 307C, 307D, and 307E of tissuesensitivity to optical stimulation for a three types or compositions oftissue as a function of the wavelength of the optical stimulation.

FIG. 3K is a schematic graph 308C of a designed power/wavelengthspectrum profile used to customize the absorption of optical power in aplurality of tissues.

FIG. 3L is a schematic graph 309C of a designed power/wavelengthspectrum profile used to customize the absorption of optical power in aplurality of tissues.

FIG. 3M includes a computer-simulation-derived plot of a temperatureprofile of tissue due to absorption of single-wavelength source 331(see, e.g., FIG. 4A) of infrared light having a first wavelength.

FIG. 4 is a plot of a temperature profile of tissue due to absorption ofsingle-wavelength source of infrared light.

FIG. 4A is a schematic diagram that includes a plot of a temperatureprofile of tissue due to absorption of single-wavelength source 331 ofinfrared light having a first wavelength.

FIG. 4B is a schematic diagram that includes a plot of a temperatureprofile of tissue due to absorption of single-wavelength source 332 ofinfrared light having a second wavelength.

FIG. 4C is a schematic diagram that includes a plot of a temperatureprofile of tissue due to absorption of single-wavelength source 333 ofinfrared light having a third wavelength.

FIG. 4D is a schematic diagram that includes a plot of a temperatureprofile of tissue due to absorption of source 330A of infrared lighthaving a customized spectrum of wavelengths.

FIG. 4E is a schematic diagram that includes a plot of a temperatureprofile of tissue due to absorption of source 330B of infrared lighthaving a customized spectrum of wavelengths.

FIG. 4F is a schematic graph 409A of a designed power/wavelengthspectrum profile for a time period N in a sequence of time periods N,N+1, N+2 used to customize the temporal absorption of optical power in aplurality of tissues.

FIG. 4G is a schematic graph 409B of a designed power/wavelengthspectrum profile for a time period N+1 in a sequence of time periods N,N+1, N+2 used to customize the temporal absorption of optical power in aplurality of tissues.

FIG. 4H is a schematic graph 409C of a designed power/wavelengthspectrum profile for a time period N+2 in a sequence of time periods N,N+1, N+2 used to customize the temporal absorption of optical power in aplurality of tissues.

FIG. 5 is a schematic representation of a system 500 having an implanteddevice 110, an optional externally worn device 111 and a transceiver 71of customization console computer such as shown in FIG. 1.

FIG. 6A is a flow chart of a method 601, according to some embodimentsof the present invention.

FIG. 6B is a flow chart of a method 602, according to some embodimentsof the present invention.

FIG. 7 is a flow chart of a method 700, according to some embodiments ofthe present invention.

FIG. 8A is a flow chart of a method 801, according to some embodimentsof the present invention.

FIG. 8B is a graph of a binned-channel-with-history spectrum 802,according to some embodiments of the present invention.

FIG. 9 is a flow chart of a method 900, according to some embodiments ofthe present invention.

FIG. 10 is a flow chart of a method 1000, according to some embodimentsof the present invention.

FIG. 11 is a diagram of the firing of auditory nerve cells 1100 as haircells are deflected.

FIG. 12 is a graph 1200 of auditory nerve firing rates versus soundlevel.

FIG. 13 is a graph 1300 of auditory nerve firing rate versus soundlevel.

FIG. 14 is a graph 1400 of perceived sound level versus auditory nervefiring rate.

FIG. 15 is a set of graphs 1500 of test subject loudness perception atdiffering stimulation rates.

FIG. 16 is a set of graphs 1600 of test subject average auditory nervespike probability versus stimulation rate.

FIG. 17A is a graph 1701 of signal current level for variousauditory-nerve-stimulation rates.

FIG. 17B is a graph 1702 of signal current level for variousauditory-nerve-stimulation rates.

FIG. 18A is a graph 1801 of action potential rates versus frequency foracoustically stimulated nerves.

FIG. 18B is a set of graphs 1802 of the distribution of numbers ofneurons versus frequency.

FIG. 18C is a graph 1803 of nerve action potential response rate versusstimulation rate.

FIG. 18D is a graph 1804 of nerve firing efficiency versus stimulationrate.

FIG. 19 is a graph 1900 of phoneme recognition as a function ofstimulation rate.

FIG. 20 is a graph 2000 of phoneme recognition as a function of stimulusdynamic range.

DETAILED DESCRIPTION OF THE INVENTION

Although the following detailed description contains many specifics forthe purpose of illustration, a person of ordinary skill in the art willappreciate that many variations and alterations to the following detailsare within the scope of the invention. Very narrow and specific examplesare used to illustrate particular embodiments; however, the inventiondescribed in the claims is not intended to be limited to only theseexamples, but rather includes the full scope of the attached claims.Accordingly, the following preferred embodiments of the invention areset forth without any loss of generality to, and without imposinglimitations upon the claimed invention. Further, in the followingdetailed description of the preferred embodiments, reference is made tothe accompanying drawings that form a part hereof, and in which areshown by way of illustration specific embodiments in which the inventionmay be practiced. It is understood that other embodiments may beutilized and structural changes may be made without departing from thescope of the present invention.

The embodiments shown in the Figures and described here may includefeatures that are not included in all specific embodiments. A particularembodiment may include only a subset of all of the features described,or a particular embodiment may include all of the features described.

The leading digit(s) of reference numbers appearing in the Figuresgenerally corresponds to the Figure number in which that component isfirst introduced, such that the same reference number is used throughoutto refer to an identical component which appears in multiple Figures.Signals and connections may be referred to by the same reference numberor label, and the actual meaning will be clear from its use in thecontext of the description.

FIG. 1 is an overview diagram of a hardware- and operating-environment(or system) 100 that is used in conjunction with embodiments of theinvention. The description of FIG. 1 is intended to provide a brief,general description of suitable computer hardware and a suitablecomputing environment in conjunction with which the invention may beimplemented. In some embodiments, the invention is described in thegeneral context of computer-executable instructions, such as programmodules, that are stored on computer-readable media and that areexecuted by a computer, such as a microprocessor residing in animplanted device (located within a patient) and/or in an external deviceworn by the patient and/or personal computer that is/are wirelesslylinked to the implanted device. Generally, program modules includeroutines, programs, objects, components, data structures, and the like,that perform particular tasks or implement particular abstract datatypes.

In some embodiments, system 100 includes an audiologist- and/oruser-control console computer 20 that is programmable and that has awireless transceiver 71 that allows wireless control (i.e.,reprogramming of the remote microprocessors) of the implanted device 110(which includes a programmed microcontroller), and/or an externally worndevice 111 (which also includes a programmed microcontroller) thatwirelessly communicates and/or provides power to the implanted device110. In some embodiments, application programs 36 stored on acomputer-readable storage device (e.g., optical disk 31 (CDROM, DVD,Blu-ray Disc™ (BD), or the like), magnetic or FLASH storage device 29(e.g., floppy disk, thumb drive, SDHC™ (Secure-Data High-Capacity)memory card or the like), and/or a storage device 50 connected to aremote computer 49 that connects to computer 20 across a local-areanetwork 51 or a wide-area network 52 such as the internet) containinstructions and/or control structures (such as look-up tables, controlparameters, databases and the like) that are processed and/ortransmitted into the implanted device 110 to control its operation bymethods of the present invention described herein. In some embodiments,the applications programs 36 are partially executed in the computer 20and/or the externally worn device 111, and then partially executed inthe implanted device 110.

Accordingly, in some embodiments, an audiologist and/or user can adjustparameters of the implanted optical-electrical-cochlear-stimulationdevice 110 to customize its operation to a much greater extent than ispossible with a conventional electrical-stimulation cochlear implant,because implanted optical-electrical-cochlear-stimulation device 110 hasa far greater number of parameters that can be finely adjusted (e.g.,pulse width, amplitude, frequency, wavelength, polarization, wavelengthprofile, beam profile, beam angle, and, the like). In some embodiments,the applications programs 36 contain a substantial amount of safetycontrol code that runs in computer 20 to guide the audiologist and/oruser to adjust the parameters of the implantedoptical-cochlear-stimulation device 110 and to help prevent operationthat might harm the patient or damage the implanted device 110 (such aswhat might occur if too much optical energy were applied in aconcentrated small area of the cochlea or within too short a period oftime, or if overheating occurred in the device 110 due to too manyVCSELs (vertical-cavity surface emitting lasers) next to one anotherbeing activated in a short period of time).

Although many of the embodiments herein have light-emitting elementsthat include VCSELs (vertical-cavity surface emitting lasers)implemented as electrically pumped semiconductor diode lasers, otherembodiments of the present invention use edge-emitting semiconductordiode lasers, optically pumped semiconductor lasers, optically pumpedoptical-fiber lasers, light-emitting diodes, superluminescent devices,or any other suitable light source. Some embodiments use wavelengths inthe range of 1.75 microns to 2 microns, other embodiments use any othersuitable wavelengths.

Moreover, those skilled in the art will appreciate that the inventionmay be practiced with other computer-system configurations, includinghand-held devices, multiprocessor systems, microprocessor-based orprogrammable consumer electronics, network PCs, minicomputers, mainframecomputers, and the like. The invention may also be practiced indistributed computer environments where tasks are performed by remoteprocessing and input-output (I/O) devices that are linked through acommunications network. In a distributed-computing environment, programmodules may be located in both local and remote storage devices.

As shown in FIG. 1, in some embodiments, the hardware- andoperating-environment includes audiologist- and/or user-control consolecomputer 20, or a server 20, including a processing unit 21, a systemmemory 22, and a system bus 23 that operatively couples various systemcomponents including the system memory 22 to the processing unit 21. Insome embodiments, there may be only one, or in other embodiments, theremay be more than one processing unit 21, such that the processor ofcomputer 20 comprises a single central-processing unit (CPU), or aplurality of processing units, commonly referred to as a multi-processoror parallel-processing environment. In various embodiments, computer 20may be implemented using a conventional computer, a distributedcomputer, or any other type of computer including those embedded in cellphones, personal-data-assistant devices or other form factors.

The system bus 23 can be any of several types of bus structuresincluding a memory bus or memory controller, a peripheral bus, and alocal bus using any of a variety of bus architectures. The system memorycan also be referred to as simply the memory, and includes read-onlymemory (ROM) 24 and random-access memory (RAM) 25. A basic input/outputsystem (BIOS) 26, containing the basic routines that help to transferinformation between elements within the computer (or server) 20, such asduring start-up, may be stored in ROM 24. The computer 20 furtherincludes a hard disk drive 27 for reading from and writing to a magnetichard disk, a removable-media drive or FLASH controller 28 for readingfrom or writing to a removable magnetic floppy-disk or FLASH storagedevice 29, and an optical disk drive 30 for reading from or writing to aremovable optical disk 31 (such as a CDROM, DVD, Blu-ray Disc™ (BD) orother optical media).

The hard disk drive 27, magnetic disk drive 28, and optical disk drive30 couple with a hard disk drive interface 32, a magnetic disk driveinterface 33, and an optical disk drive interface 34, respectively. Thedrives and their associated computer-readable media providenon-volatile, non-ephemeral storage of computer-readable instructions,data structures, program modules and other data for the computer 20. Itshould be appreciated by those skilled in the art that any type ofcomputer-readable media which can store data that is accessible by acomputer, such as magnetic cassettes, FLASH memory cards, digital videodisks, Bernoulli cartridges, random-access memories (RAMs), read-onlymemories (ROMs), redundant arrays of independent disks (e.g., RAIDstorage devices) and the like, can be used in the exemplary operatingenvironment.

A plurality of program modules that implement the optimization methodsof the present invention can be stored on the hard disk, magnetic orFLASH storage device 29, optical disk 31, ROM 24, or RAM 25, includingan operating system 35, one or more application programs 36, otherprogram modules 37, and program data 38. A plug-in program containing asecurity transmission engine for the present invention can be residenton any one, or on a plurality of these computer-readable media.

In some embodiments, a user (e.g., the audiologist or the patient)enters commands and perception information into the computer 20 throughinput devices such as a keyboard 40, pointing device 42 or othersuitable device such as a microphone (not shown). Other input and/oroutput devices (not shown) can include a microphone, joystick, game pad,satellite dish, scanner, speaker, headphones or the like. These otherinput and output devices are often connected to the processing unit 21through a serial port interface 46 that is coupled to the system bus 23,but can be connected by other interfaces, such as a parallel port, gameport, or a universal serial bus (USB); a monitor 47 or other type ofdisplay device can also be connected to the system bus 23 via aninterface, such as a video adapter 48. The monitor 47 can display agraphical user interface for the audiologist and/or user. In addition tothe monitor 47, computers typically include other peripheral outputdevices (not shown), such as speakers and printers.

In some embodiments, computer 20 operates in a networked environmentusing logical connections to one or more remote computers or servers,such as remote computer 49. These logical connections are achieved by acommunication device coupled to or a part of the computer 20; theinvention is not limited to a particular type of communications device.The remote computer 49 can be another computer, a server, a router, anetwork PC, a client, a peer device or other common network node, andtypically includes many or all of the elements described above relativeto the computer 20, although only memory storage device 50 andapplication programs 36 have been illustrated in FIG. 1. The logicalconnections depicted in FIG. 1 include local-area network (LAN) 51 andwide-area network (WAN) 52. Such networking environments are commonplacein office networks, enterprise-wide computer networks, intranets and theInternet, which are all types of networks.

When used in a local-area networking (LAN) environment, the computer 20is connected to the LAN 51 through a network interface, modem or adapter53, which is one type of communications device. When used in a wide-areanetworking (WAN) environment such as the internet, the computer 20typically includes an adaptor or modem 54 (a type of communicationsdevice), or any other type of communications device, e.g., a wirelesstransceiver, for establishing communications over the wide area network52, such as the internet. The modem 54, which may be internal orexternal, is connected to the system bus 23 via the serial portinterface 46. In a networked environment, program modules depictedrelative to the personal computer 20, or portions thereof, (or thosestored in the externally worn device 111 or the implanted device 110)can be stored in the remote memory storage device 50 of remote computer(or server) 49 and accessed over the internet or other communicationsmeans. Note that the transitory signals on the internet may move storedprogram code from a non-transitory storage medium at one location to acomputer that executes the code at another location by the signals onone or more networks. The program instructions and data structuresobtained from a network or the internet are not “stored” on the networkitself, but are stored in non-transitory storage media that may beconnected to the internet from time to time for access. It isappreciated that the network connections shown are exemplary, and insome embodiments, other means of, and communications devices for,establishing a communications link between the computers may be usedincluding hybrid fiber-coax connections, T1-T3 lines, DSL's, OC-3 and/orOC-12, TCP/IP, microwave, WAP (wireless application protocol), and allother electronic media through standard switches, routers, outlets andpower lines, as the same are known and understood by one of ordinaryskill in the art.

The hardware and operating environment in conjunction with whichembodiments of the invention may be practiced has been described. Thecomputer 20 in conjunction with which embodiments of the invention canbe practiced can be a conventional computer, a distributed computer, orany other type of computer; the invention is not so limited. Such acomputer 20 typically includes one or more processing units as itsprocessor, and a computer-readable medium such as a memory. The computer20 can also include a communications device such as a network adapter ora modem, so that it is able to communicatively couple to othercomputers, servers, or devices.

In some embodiments, one or more parts of system 100 elicits andreceives input from a user, and based on the input, modifies, adjusts orexecutes one or more of the methods of the present invention asdescribed herein.

FIG. 2A is a schematic diagram of a VCSEL-based implanted stimulationsystem 200 that is coiled from a base end (that is electricallyconnected to a driver circuit 250 via electrical connection substrateribbon 212) to an apex end, such that the coiling of system 200 matchesthe coiling of cochlea 85 and is inserted into cochlea 85. In someembodiments, system 200 is configured to be inserted within a length ofcochlea 85 (forming the inserted intra-cochlear portion 210), while inother embodiments, system 200 is configured to be placed outside andalong the exterior of cochlea 85. In some embodiments, system 200includes a plurality of VCSEL sources 244 configured to direct opticallystimulating light pulses to excitable tissue in the cochlea of a personin order to trigger nerve action potentials in one or more auditorynerve pathways of the cochlea.

The basilar membrane within the cochlea 85 of the inner ear is a stiffstructural element that separates two liquid-filled tubes (the scalamedia 86 and the scala tympani 89) that run along the coil of thecochlea, and that contains the organ of cord 88. A third liquid-filledtube that runs along the coil of the cochlea, the scala vestibuli 87, isseparated from the scala media 86 by Reissner's membrane, and has afluid that is different than that of the scala media 88 and the scalatympani 89. High frequencies are detected by nerves nearest the basalend (where the basilar membrane is stiffest), while low frequencies aredetected by nerves nearest the apical end of the cochlea 85. Thus, whenan optical-stimulation device cannot be inserted far enough towards theapical end, it is the low-frequency sensations that cannot bestimulated. Therefore, in some embodiments, the intra-cochlear portion210 of system 200 includes one or more signal electrodes 246 (in someembodiments, the intra-cochlear portion 210 optionally includes one ormore return (or ground) electrodes 247 to provide a nearby electricalground for return current in a portion of the cochlea across from theelectrodes 246, so as to provide an electrical field that extends acrossone or more stimulate-able nerves in the cochlea. In other embodiments,electrodes are arranged in pairs of (or groups of two or more)electrodes that are driven by bi-phasic differentialelectrical-stimulation signals, either of which, at different times canbe more positive than the other, and the signals are generated toprevent ionic-charge build-up in the tissue located deep in the apicalend of cochlea 85.

In some such embodiments, electrodes 246 are configured to provideelectrical stimulation for the apical spiral ganglion cells at the lowerfrequency range. Electrical stimulation can access these deeper regionsof cochlea 85 because of the spread of electricity that occurs duringelectrical stimulation (in some embodiments, there is no spreading ofthe optical signal to illuminate the cells beyond the tip of the lastVCSEL source 244). In some embodiments, the one or more electrodes 246are covered by an insulating sheath 245 that is configured toelectrically isolate the one or more intra-cochlear electrodes 246 (andoptionally 247) from each other and to help orient the electrical fieldbetween the intra-cochlear electrode(s). In some embodiments, insulatingsheath 245 is further configured to electrically isolate the VCSELsources 244 from the one or more electrodes 246/247. In some embodimentsof the system 200 of FIG. 2, the electrical-stimulation portions(electrodes 246/247 and insulating sheath 245) and are omitted and onlythe optical-stimulation portions are implemented. In some suchembodiments, instead of using electrodes 246 to stimulate the lowerfrequency range, one or more VCSEL sources 244 located at the far apexend of substrate 243 are directed into the apical end of cochlea 85 atangles sufficient to stimulate the lower frequency range. In someembodiments, at least the stimulation-emission end (the intra-cochlearportion 210 from which optical and electrical-stimulation signals areemitted) of the cochlear implant is implanted within, and along a lengthof, the scala tympani 89. In other embodiments, at least the stimulationemission end of the cochlear implant is implanted within, and along alength of, the scala vestibuli 87. In some embodiments, the controllerportion is external to the cochlea, and a feed-through conduit goesthrough either the round window and/or the oval window (depending onwhere the intra-cochlear portion 210 is located) of the cochleaconnecting the controller to the intra-cochlear portion 210 (inside thescala tympani 89 and/or scala vestibuli 87), wherein the feed-throughconduit 248 is coated with a bio-compatible material so that the roundwindow and/or the oval window membrane seals to the feed-through conduit248. In other embodiments, the entire implanted system 200 is within thescala tympani 89 or the scala vestibuli 87, or even the scala media 86of the cochlea 85.

In some embodiments, the one or more electrodes 246 at the apical end ofthe implant are inserted to a location that is at least 50% of thebasal-to-apical length of the cochlear channel (whichever channel isused for the implant) toward the apical end of the intra-cochlearportion 210 of the implant, as measured from the basilar membrane (i.e.,the electrodes are closer to the apical end than to the basal end of thecochlea). In some embodiments, the one or more electrodes 246 at theapical end of the implant are inserted to a location that is at least75% of the basal-apical length toward the apical end of theintra-cochlear portion 210 of the implant (i.e., much closer to theapical end than to the basal end). In some embodiments, the one or moreelectrodes 246 at the apical end of the implant are inserted to alocation that is at least 90% of the basal-apical length toward theapical end of the intra-cochlear portion 210 of the implant (i.e.,substantially at the apical end).

In some embodiments, each of the VCSEL sources 244 is located on asurface of substrate 243 that faces the organ of corti from insidecochlea 85 (e.g., in some embodiments, substrate 243 extends inside thescala tympani 89 (the lower channel) in cochlea 85 from near the base tonear the apex, such that each VCSEL array 244 emits light toward theorgan of corti 88). In some embodiments, no portion of system 200 isinserted into the scala vestibuli channel 87 of cochlea 85. In someembodiments, each VCSEL source 244 emits infrared optical-stimulationsignals.

In some embodiments, each VCSEL array 244 has a plurality of emittersthat emit light for one or more sensory frequency channels (each sensoryfrequency channel being the nerve pathway from hair cells located torespond to a particular audio frequency and to initial NAPs in one ofthe auditory nerve pathways associated with that frequency). In someembodiments, two rows of five VCSEL emitters extend across a width ofeach VCSEL array 244, while in other embodiments, other numbers of rowsand other numbers of VCSEL emitters per row are provided. In someembodiments, via testing and mapping after implantation, one or more ofthe VCSEL emitters in one row is mapped and used to stimulate NAPs forone sensory frequency channel, while one or more of the VCSEL emittersin another row is mapped and used to stimulate NAPs for another sensoryfrequency channel. In some embodiments, multiple VCSELs are provided ineach row (e.g., in some embodiments, many more than end up actuallybeing used) in order that, to accommodate placement errors, testing ofall or most of the stimulation sources, and then mapping of whichstimulation causes each of a plurality of sensory responses orperceptions so that only the subset of stimulation sources that are mosteffective in causing a response are used to generate NAPs based on theinformation content of the audio signal. In some embodiments, VCSELarrays that emit a plurality of different wavelengths are used tocustomize the spatial absorption profile of the stimulation light.

In some embodiments, each VCSEL source 244 includes a single VCSEL,while in other embodiments, each VCSEL source 244 includes a pluralityof individually activatable lasers oriented to emit light alongsubstantially parallel axes with somewhat overlapping spots ofillumination (such that, in some embodiments, one or more of the groupof VCSELs can be individually activated at a succession of differenttimes after implantation, in order to dynamically determine which of theplurality of VCSELs in a single array 244 is best suited to stimulateone or more nerves that are very near to one another, but for which itis desired to selectively stimulate one or more individually withoutstimulating the adjacent neighboring nerves). In other embodiments, eachgroup of VCSELs 244 is configured to emit laser-light beams in aplurality of non-parallel directions to stimulate nerves that are notright next to one another. In some embodiments, each group of VCSELs 244has an associated one or more focussing devices to focus the light(e.g., graded-index-fiber (GRIN) lenses, diffraction gratings orholographs, or other suitable microlenses that either disperse thelight, in some embodiments, or in other embodiments focus the light to asmall spot of excitable tissue such as hair cells in cochlea 85 orspiral ganglion cells (SGCs)), while in other embodiments, no lenses areused. In some embodiments, a plurality of channels (e.g., two to ahundred or more channels) each has one or more VCSELs (e.g., in someembodiments, 1 to 5 to more VCSELs per channel), such that one or moreof the VCSELs on a given channel can be selectively activated tostimulate nerves associated with that channel. In some embodiments, aplurality of VCSELs are each activated to trigger NAPs in additionalneighboring spiral ganglion cells, and/or to increase thepulse-repetition rate of NAPs in a particular set of nerve pathways inorder to provide loudness control, as mentioned earlier. In someembodiments, each VCSEL is connected to two electrical conductors(namely, its individual signal conductor and a common or groundconductor that is shared with other VCSEL emitters). In someembodiments, an array of VCSELs is arranged such that all VCSELs in anyone row share an anode connection and all VCSELs in any one column sharea cathode connection, and such that each VCSEL emitter is uniquelyaddressed by electrically driving its row anode and its column cathode(of course, the terms row and column can be interchanged).

In some embodiments, the implanted device of the present inventionincludes a sound sensor (microphone; not shown) that, upon activation byan external sound (pressure wave), generates one or more electricalsignals. In some embodiments, a computerized sound analyzer decomposesthe audio signal (e.g., using a fast Fourier transform (FFT), discretecosine transform (DCT), or other suitable digital signal processor (DSP)or analog means) to output time-varying frequency components. In someembodiments, the optical-stimulation signals from VCSEL arrays 244 andelectrical-stimulation signals are generated based on the outputtedtime-varying frequency components signals.

FIG. 2B is a perspective view of VCSEL-based stimulation system 200showing a cut-away view of cochlea 85. In some embodiments, system 200includes a plurality of VCSEL sources 244 configured to direct opticallystimulating light pulses to excitable tissue in the cochlea of a personin order to trigger nerve action potentials in the auditory nerve 91 ofthe person. In some embodiments, system 200 includes a first electrode246A and a second electrode 246B located deep in the apical end ofcochlea 85. In some such embodiments, electrodes 246A and 246B areelectrically isolated from each other by insulating sheaths 245. In someembodiments, system 200 is configured to optically stimulate auditorynerve 91 by directing a plurality of pulsed light signals at one or morelocations on the organ of corti 88. In other embodiments, system 200 isconfigured to optically stimulate auditory nerve 91 by directing aplurality of pulsed light signals at one or more nerves 98 that arelocated in the pathway between the organ of corti 88 and the auditorynerve 91. For example, in some embodiments, VCSEL source 244A directs apulsed laser beam 84A at a first location of one or more nerves 98 andVCSEL source 244B directs a pulsed laser beam 84B at a second locationof one or more nerves 98.

FIG. 2C is a schematic perspective exploded-view diagram illustratinglight-emitting, light-focussing, and/or light-pointing device 205, usedto implement some embodiments of VCSEL emitters 244 of FIG. 2B. In someembodiments, each device 205 includes a semiconductor chip 252 havingplurality of VCSELs 251 arranged in an array (e.g., in some embodiments,a Cartesian grid, while in other embodiments, any other suitablepattern) that allows a large number of VCSELs to be implanted such thateach directs its light to a slightly different location, and such that amuch smaller number of the VCSELs is activated at any one time (e.g., insome embodiments, some VCSELs may never be activated except duringtesting, calibration and customization, while others may be used more orless frequently depending on whether their neighboring VCSELs areactivated to emit stimulation light or have recently been activated). Insome embodiments, an array or other structure of focussing elements 254(e.g., microlenses, holographs, GRIN lenses or the like) and/orangle-pointing elements 256 (e.g., a plurality of prisms (as shown inFIG. 2C), gratings, MEMS mirrors, or the like) are provided to focus,and/or point the stimulation light in various angular directions,towards the nerves to be stimulated. In some embodiments, a plurality ofsuch light-emitting devices 205 is used as the light-source elements 244of FIG. 2A and FIG. 2B affixed along the length of ribbon 212. In somesuch embodiments, ribbon 212 includes a plurality of electricalconnections arranged to multiplex signals to independently activateselected ones of the VCSELs, and optionally includes ahigh-thermal-conductivity material configured to remove excess deviceheat from within the cochlea. In some embodiments, ribbon 212 furtherincludes one or more thermal sensors (e.g., in some embodiments,implemented on the light-emitting device 205, while in otherembodiments, implemented on separate devices also located along ribbon212) that transmit temperature-indicating signals from the cochlea tocontroller 250.

FIG. 3M includes a schematic graph 300 of the tissue absorption 302(which is one indication of the sensitivity to stimulation light) of atissue at various wavelengths in a given range, and a superimposed graph301 of a power-source spectrum having different amounts of power at eachof a plurality of wavelengths, which has been customized to provide adesired spatial heating profile due to absorption of infrared lighthaving the various wavelengths. In some embodiments of the presentinvention as shown in any of the figures herein, the range ofwavelengths in the power-source spectrum is at least 2.5 nm. In someembodiments, the range of wavelengths in the power-source spectrum is atleast 5 nm. In some embodiments, the range of wavelengths in thepower-source spectrum is between about 5 nm and about 10 nm. In someembodiments, the range of wavelengths in the power-source spectrum isbetween about 10 nm and about 15 nm. In some embodiments, the range ofwavelengths in the power-source spectrum is between about 15 nm andabout least 20 nm. In some embodiments, the range of wavelengths in thepower-source spectrum is between about 20 nm and about 30 nm. In someembodiments, the range of wavelengths in the power-source spectrum isbetween about 30 nm and about 40 nm. In some embodiments, the range ofwavelengths in the power-source spectrum is more than 40 nm.

In some embodiments, the wavelengths of the optical power source are inthe range of about 800-900 nm. In some embodiments, the wavelengths ofthe optical power source are in the range of about 900-1000 nm. In someembodiments, the wavelengths of the optical power source are in therange of about 1000-1100 nm. In some embodiments, the wavelengths of theoptical power source are in the range of about 1100-1200 nm. In someembodiments, the wavelengths of the optical power source are in therange of about 1200-1300 nm. In some embodiments, the wavelengths of theoptical power source are in the range of about 1300-1400 nm. In someembodiments, the wavelengths of the optical power source are in therange of about 1400-1500 nm. In some embodiments, the wavelengths of theoptical power source are in the range of about 1500-1600 nm. In someembodiments, the wavelengths of the optical power source are in therange of about 1600-1700 nm. In some embodiments, the wavelengths of theoptical power source are in the range of about 1700-1800 nm. In someembodiments, the wavelengths of the optical power source are in therange of about 1800-1900 nm (in some embodiments, this is a morepreferred range). In some embodiments, the wavelengths of the opticalpower source are in the range of about 1900-2000 nm. In someembodiments, the wavelengths of the optical power source are in therange of about 2000-2100 nm. In other embodiments, the wavelengths ofthe optical power source extend across (include two or more differentwavelengths within (i.e., two or more spectrally separated wavelengthswithin)) one or more of these ranges.

In some embodiments, within the selected range of stimulationwavelengths, the tissue-absorption value increases as the wavelengthincreases (as shown by graph 302 of FIG. 3M and graph 307A of FIG. 3B)and the optical-stimulation power at each of a plurality of wavelengthsdecreases as the wavelength increases (as shown by graph 301 of FIG. 3M,graph 308A of FIG. 3D, and graph 309A of FIG. 3F). In other embodiments,within the selected range of stimulation wavelengths, thetissue-absorption value decreases as the wavelength increases (as shownby graph 307B of FIG. 3G and graphs 307D and 307C of FIG. 3J) and theoptical-stimulation power at each of a plurality of wavelengthsincreases as the wavelength increases (as shown by graph 308B of FIG. 3Hand graph 309B of FIG. 3I).

FIG. 3A is a conceptual schematic diagram of a broadband wavelengthsource 310 having a designed power/wavelength spectrum profile formed tocustomize the absorption of optical power in the tissue of interest. Insome embodiments, broadband wavelength source 310 includes a laserhaving a reflective grating or other means for generating differentamounts of light output at various wavelengths (such as shown in FIG. 3Ddescribed below). Source 310 is controlled by an electrical signal 317to emit pulsed light 318 having a spectrum such as shown in FIG. 3D,FIG. 3H, or FIG. 3K, as desired by the designer. In some embodiments,the wavelength range (e.g., full-width half-maximum (FWHM) range ofwavelengths) of the optical-source power spectrum is at least 2.5 nm. Insome embodiments, the range of wavelengths in the optical-source powerspectrum is at least 5 nm. In some embodiments, the range of wavelengthsin the optical-source power spectrum is between about 5 nm and about 10nm. In some embodiments, the range of wavelengths in the optical-sourcepower spectrum is at least about 10 nm wide and less than about 100 nm(in some embodiments, this is a preferred range). In some embodiments,the range of wavelengths in the optical-source power spectrum is betweenabout 10 nm and about 15 nm. In some embodiments, the range ofwavelengths in the optical-source power spectrum is between about 15 nmand about least 20 nm. In some embodiments, the range of wavelengths inthe optical-source power spectrum is between about 20 nm and about 30nm. In some embodiments, the range of wavelengths in the optical-sourcepower spectrum is between about 30 nm and about 40 nm. In someembodiments, the range of wavelengths in the optical-source powerspectrum is more than 40 nm. In some embodiments, theoptical-stimulation signal includes two or more different wavelengthswithin (i.e., two or more spectrally separated wavelengths within) oneor more of these ranges.

FIG. 3B includes a schematic graph 307A of a tissue sensitivity tooptical stimulation for a first given type or composition of tissue as afunction of the wavelength of the optical stimulation. In someembodiments, graph 307A is representative of light absorption at variouswavelengths. Note that in some wavelength ranges the sensitivity willincrease at longer wavelengths such as shown in FIG. 3B, while in otherembodiments, the sensitivity will decrease at longer wavelengths such asshown in FIG. 3G, while in still other embodiments, the sensitivity peakat different wavelengths for different tissue types, such as shown inFIG. 3J, as described below.

FIG. 3C is a schematic diagram of a broadband wavelength source 320having a designed power/wavelength spectrum profile formed to customizethe absorption of optical power in the tissue of interest. In someembodiments, source 320 includes a conventional broadband source 321having a broad Gaussian linewidth (e.g., a laser (such as avertical-cavity surface-emitting laser (VCSEL) or optically-pumped fiberlaser) or superluminescent light-emitting diode or filtered amplifiedspontaneous emission (ASE) fiber source) which is controlled byelectrical signal 327 to emit pulsed light 322. The pulsed light passesthrough a shaped-spectrum filter 323 such that output of the broadbandwavelength source 320 emits pulsed light 328 having a spectrum such asshown in FIG. 3D, FIG. 3H, or FIG. 3K, as desired by the designer.

FIG. 3D is a schematic graph 308A of a designed power/wavelengthspectrum profile used to customize the absorption of optical power inthe tissue.

FIG. 3E is a schematic diagram of a broadband wavelength source 330having a designed power/wavelength spectrum profile formed to customizethe absorption of optical power in a tissue of interest. In someembodiments, the power spectrum is designed to compensate for the shapeof the tissue absorption characteristics (such as shown in FIG. 3B), inorder to obtain the desired heat profile (such as shown in FIG. 4D(showing activation of NAPs substantially equally at different depths)or as shown in FIG. 4E (showing activation of NAPs differently atdifferent depths)). In some embodiments, a plurality of narrow-bandlasers 331 are controlled by a plurality of independent electricalsignals 337.1, 337.2, . . . 337.N, such that the power at each laserwavelength can be varied, and when the outputs of the individual lasersare combined with a beam combiner 334, the broadband wavelength source330 has an output beam 339 having a spectrum such as shown in FIG. 3F,or as desired by the designer. In some embodiments, the plurality ofnarrow-band lasers 331 are controlled by a plurality of independentelectrical signals 337.1, 337.2, . . . 337.N, such that the power ateach laser wavelength can be varied over time with different waveshapesand/or pulses at different times, resulting in spectra that vary overtime such as shown in FIGS. 4F, 4G, and 4H described below.

FIG. 3F is a schematic graph 309A of a designed power/wavelengthspectrum profile used to customize the absorption of optical power in atissue. In some embodiments, the power/wavelength spectrum profile ofgraph 309A is obtained by combining a plurality of light signals from aplurality of narrow-band lasers 331.

FIG. 3G is a schematic graph 307B of a tissue sensitivity to opticalstimulation for a second given type or composition of tissue as afunction of the wavelength of the optical stimulation. In contrast tothe chosen tissue type and wavelength range shown in FIG. 3B above, thistissue type has decreased sensitivity (e.g., due to decreasedabsorption) at longer wavelengths.

FIG. 3H is a schematic graph 308B of a designed power/wavelengthspectrum profile used to customize the absorption of optical power inthe tissue having the sensitivity of the graph 307B of FIG. 3G.

FIG. 3I is a schematic graph 309B of a designed power/wavelengthspectrum profile used to customize the absorption of optical power in atissue. In some embodiments, the power/wavelength spectrum profile ofgraph 309B is obtained by a device such as shown in FIG. 3E describedabove.

FIG. 3J includes schematic graphs 307C, 307D, and 307E of tissuesensitivity to optical stimulation for a three types or compositions oftissue as a function of the wavelength of the optical stimulation. For agroup of such tissue types, it is sometimes desirable to have some ofthe tissues (e.g., those of graphs 307D and 307E) absorb the stimulationlight and be heated enough to trigger NAPs, while having some others ofthe tissues (e.g., those of graph 307C) not absorb enough energy totrigger NAPs.

FIG. 3K is a schematic graph 308C of a designed power/wavelengthspectrum profile used to customize the absorption of optical power in aplurality of tissues. Such a broad spectrum is useful in cases when itis desired to trigger NAPs in all the tissue types of the graphs of FIG.3J.

FIG. 3L is a schematic graph 309C of a designed power/wavelengthspectrum profile used to customize the absorption of optical power in aplurality of tissues. Such a selectively activated spectrum is useful incases when it is desired to trigger NAPs in some of the tissues (e.g.,those of graphs 307D and 307E of FIG. 3J), while having some others ofthe tissues (e.g., those of graph 307C) not absorb enough energy totrigger NAPs.

FIG. 4 is a plot 400 of a temperature profile of tissue due toabsorption of infrared light from a single-wavelength source. In thisplot, the tissue vertically in the center and horizontally at the left(in an innermost ring) is heated to (e.g., in this example) to 42° C.(42 degrees centigrade), which in some embodiments, is sufficient totrigger a NAP if a nerve were located at that position. The tissue tothe right of a tissue depth of 2 mm remains at 37.5° C. (normal bodytemperature), while intermediate tissue is heated, but not enough totrigger NAPs even if nerves were located there.

FIG. 4A is a schematic diagram that includes a hypothetical plot 440 ofa temperature profile of tissue due to absorption of light fromsingle-wavelength source 331 of infrared light having a firstwavelength. The oval lines represent equi-temperature locations, withline 446 representing the tissue area having the highest temperature(this would be the temperature needed to trigger NAPs in nerves, sincethe controller will strive to prevent stimulation signals that result inhigher temperature, since those are not more effective at triggeringNAPs and are likely to damage tissue). Each of the otherequi-temperature lines (lines 445, 444, 443, 442 and 441) representsuccessively lower temperatures, each of which is too low to triggerNAPs. Of the nerves 81, 82, and 83 in the tissue 80, only the nerve 81is located within the 446 line, and so it, but not the others, will havea NAP triggered.

FIG. 4B is a schematic diagram that includes a plot 440 of a temperatureprofile of tissue due to absorption of single-wavelength source 332 ofinfrared light having a second wavelength. Again, the oval linesrepresent equi-temperature locations, with line 446 representing thetissue area having the temperature needed to trigger NAPs in nerves. Ofthe nerves 81, 82, and 83 in the tissue 80, only the nerve 82 is locatedwithin this 446 line, and so it, but not the others, will have a NAPtriggered.

FIG. 4C is a schematic diagram that includes a plot 440 of a temperatureprofile of tissue due to absorption of single-wavelength source 333 ofinfrared light having a third wavelength. Again, the oval linesrepresent equi-temperature locations, with line 446 representing thetissue area having the temperature needed to trigger NAPs in nerves. Ofthe nerves 81, 82, and 83 in the tissue 80, only the nerve 83 is locatedwithin this 446 line, and so it, but not the others, will have a NAPtriggered. In some embodiments, the threshold optical-stimulation signalextends across two of the three cases shown in FIG. 4A, FIG. 4B or FIG.4C.

FIG. 4D is a schematic diagram that includes a plot 440 of a temperatureprofile of tissue due to absorption of source 330A of infrared lighthaving a customized spectrum of wavelengths (e.g., the spectrum of FIG.3D, 3F, or 3K). Note that line 446 representing the tissue area havingthe temperature needed to trigger NAPs in nerves is larger than previouscases of FIG. 4A, FIG. 4B or FIG. 4C (extending from shallow to deep),and now covers all three of the nerves 81, 82, and 83 in the tissue 80,so all the nerves 81, 82, and 83, each at a different depth, have a NAPtriggered.

FIG. 4E is a schematic diagram that includes a plot 440 of a temperatureprofile of tissue due to absorption of infrared light from source 330Bhaving a customized spectrum of wavelengths (e.g., the spectrum of FIG.3L). Note that line 446 of FIG. 4D representing the tissue area havingthe temperature needed to trigger NAPs in nerves is now split into twoparts (both of which trigger a NAP), 446S which covers the shallow nerve81, and 446D which covers deep nerve 83, but this threshold region doesnot cover middle nerve 82 in the tissue 80, so the moderate-depth nerve82 will not have a NAP triggered. In some embodiments, wavelengths ofthe spectrum are chosen such that part (some of the wavelength(s)) ofthe stimulation optical signal are absorbed at a shallow depth (toprovide the triggering temperature labeled 446S) and part (others of thewavelength(s)) of the stimulation optical signal is absorbed at a deepdepth (to provide the triggering temperature labeled 446D).

FIG. 4F is a schematic graph 409A of a designed power/wavelengthspectrum profile for a time period N in a sequence of time periods N,N+1, N+2 used to customize the temporal absorption of optical power in aplurality of tissues.

FIG. 4G is a schematic graph 409B of a designed power/wavelengthspectrum profile for a time period N+1 in a sequence of time periods N,N+1, N+2 used to customize the temporal absorption of optical power in aplurality of tissues.

FIG. 4H is a schematic graph 409C of a designed power/wavelengthspectrum profile for a time period N+2 in a sequence of time periods N,N+1, N+2 used to customize the temporal absorption of optical power in aplurality of tissues. The time-varying sequence of different powerspectra is used, in some embodiments, to customize the triggering ofNAPs.

FIG. 5 is a block diagram of an implantable/partially implantable system500 that uses a VCSEL array for light stimulation of the auditory nerveof a person. System 500 represents one embodiment of the presentinvention, wherein a low-power, low-threshold VCSEL array 501 (e.g., aplurality of VCSEL sources such as found in system 200 shown in FIG. 2Aand FIG. 2B, and device 205 of FIG. 2C) emits laser light from each of aplurality of VCSELs, for example VCSELs implemented as an array ofseparately activatable lasers formed in a monolithic semiconductor chip.In some embodiments, each laser beam is separately controlled bylaser-and-power controller 510 that drives the laser-diode VCSELs undercontrol of a processor or circuitry 509 that generates signals that areconfigured to stimulate the tissue in response to input audio signals asdesired. In some embodiments, the drive signals are transmitted to VCSELarray 501 via electrical connection 580. In some embodiments, system 500includes wireless transceiver 71 (e.g., from a system console 100 suchas shown in FIG. 1) that allows wireless control and customizationprogramming of system 500 (via transceiver 511) and/or an externallyworn device 111. In some embodiments, externally worn device 111includes one or more microphones or similar sound sensors,audio-processing circuitry, and a wireless transmitter to send theprocessed audio signals to transceiver 511 in the intra-cochlear portionof 200 shown in FIG. 5. In some such embodiments, externally worn device111 includes one or more rechargeable batteries (which may be rechargedovernight in a recharging station while the patient sleeps) and awireless power transducer to send electrical power to device 500. Inother embodiments, implant 500 includes one or more microphones orsimilar sound sensors in the set of sensors 508 such that the implant isself contained (in some such embodiments, implant 500 itself includesone or more rechargeable batteries 507 that may be recharged overnightby a nearby wireless recharging station (which, in some embodiments, isincluded in wireless transceiver 71) while the patient sleeps.

In some embodiments, the set of sensors 508 includes one or moretemperature sensors, located in and/or along the in-body portion 589implanted within the cochlea, and configured to provide feedback tosystem 500 in order to provide a safety shutdown and/or optimize theoptical stimulation provided by system 500. In some embodiments, atleast one temperature sensor in the set of sensors 508 is implemented ineach of a plurality of VCSEL-array chips 501 to allow temperaturemonitoring throughout the cochlea.

In some embodiments, long-wavelength VCSEL devices (e.g., VCSELs havingwavelengths in the range of 1.6 to 2 microns) and/or VCSEL arrays, suchas described in U.S. Pat. No. 7,031,363 to Biard and U.S. Pat. No.7,004,645 to Lemoff (which are each incorporated herein by reference),are used for each of a plurality of VCSEL arrays 501.

With VCSEL emitters as small as about ten (10) microns (or smaller) indiameter per channel, in some embodiments, a single VCSEL chip orassembly is used to output multiple independent stimulation channels(VCSEL laser signals) in any suitable array permutation or shape, and insome embodiments, these channels are fiber coupled, lens coupled, and/ordirect light straight to a plurality of areas of tissue. In someembodiments, a combination of both fiber-coupled and direct propagationlaser output is used to stimulate tissue. In some embodiments, theVCSELS are located in device 504 outside the cochlea and optical fibersare used to fiber-couple the light to the various areas inside thecochlea.

In some embodiments, implantable/partially implantable system 500includes an electrical-stimulation driver 520 to drive electrodescontained within the implantable part of the system, 200. The drivesignals are transmitted to the electrodes via electrical connection 522.In some embodiments, these electrodes stimulate auditory nerves in theperson to improve low-frequency hearing response.

FIG. 6A is a flowchart of a method 601, according to some embodiments ofthe present invention, where the method is performed by a programmedinformation processor using stored instructions on non-transitorycomputer readable medium 690. The method 601 employs, depending on theembodiment of the invention, a plurality of collections of externallyprovided data stored in computer-readable data structures. In someembodiments, data includes patient-specific audio information, orauditory profile 685. In some embodiments, data includes general rulesfor mapping sounds from the environment onto auditory-nerve stimulators684. In some embodiments, the data includes anti-tissue-damage rules682, which, in some embodiments, includes rules based on tissue heating.In some embodiments, data includes anti-device-damage rules 681, which,in some embodiments, includes rules based on tissue heating. In someembodiments, data includes pulse shaping rules 683.

In some embodiments, audio sensors, which include one or moremicrophones 610, detect sounds in the environment around a patient (aperson) wearing the implantable or partially implantableauditory-nerve-stimulation system (cochlear implant). Signals are sentto an audio processor where real-time audio data is extracted from thesignals (function 612). In some embodiments, input signal audio data isorganized into frames, where a given frame contains information aboutthe input signal at a given point in time. In some embodiments, thisnecessary information includes the audio spectrum of the input signal.In some embodiments, an auditory channel map is produced (function 620).In some embodiments, general auditory mapping rules 684 and/or a patientspecific auditory profile 685 are used to produce the auditory channelmap. The auditory channel map is stored into computer-readable datastructures 621. In some embodiments, auditory channels are organizedinto a plurality of bins, where each bin is a set of frequency-adjacentauditory channels. The data extracted from the input signal is processedinto channels (function 622), using the stored auditory channel map 621,by determining the loudness (signal strength) of the portion of theinput signal that corresponds to each channel. This channel informationis stored (function 624) for each channel in computer-readable datastructures 686. In some embodiments, the information stored in thecomputer readable data structures 686 includes historic channelinformation, that is, the audio information from some number of previouspoints in time. In some embodiments, where the input audio signal isorganized into frames, channel information is stored for adesigner-determined number of frames, for each of a plurality offrequencies or frequency bands. The time-based (historic) channelinformation provides the operational data needed to restrict theoperation of specific light emitters to limit potential nerve damage inthe cochlea, or light-emitter (e.g., VCSEL) damage (e.g., damage thatmight occur due to accumulated heat from too many pulses to one area ofthe cochlea within a given amount of time (e.g., in some embodiments,the most recent one-second time period, for example) as re-measured onan on-going basis; or too many pulses from one VCSEL emitter in such aperiod of time). An example of a graph of one frame of information isshown in 687. In some embodiments, if the accumulated light signal froma particular received audio frequency would cause too much heat in onearea of the cochlea or one VCSEL, the pulse rate to that one area of thecochlea or one VCSEL is reduced relative to normal pulse rate for aparticular loudness in the received audio frequency band. In some suchembodiments, the pulses of a frequency that is one octave above or belowthe received audio frequency band are increased to provide a substitutethat can be perceived or understood by the patient to convey similarinformation as would have been conveyed by pulses at the normal rate forthe cochlear area normally stimulated by the received audiofrequency-band signal. In other words, if one particular received audiofrequency band receives too much signal in a given time period, thecochlear stimulation for that frequency is reduced and/or thestimulation is instead applied to one or more other cochlear regionsthat is/are an integer number of octaves away from the cochlear regionnormally stimulated for that received audio frequency or frequency band.

The channel information is processed (function 630) to generate drivecontrol signals for the VCSELs. The VCSELs are driven (function 695)such that the optical signals emitted from the VCSELs stimulate auditorynerves in the person wearing the cochlear implant so that the personperceives the audio signal detected by the microphones (or otheraudio-sensing devices). Light (the optical signal) emitted by a givenVCSEL stimulates a specific auditory nerve or nerves. Each specificauditory nerve corresponds to a particular sound frequency, and thetriggering of that auditory nerve results in the person perceiving soundof that corresponding frequency. In some embodiments, the output of theVCSELs is pulsed. In some embodiments, the intensity of the opticalsignal emitted from the VCSELs is varied in order to produce theperception of differing loudness levels. In other embodiments, theVCSELs are pulsed at varying rates such that the person to perceivesdiffering loudness levels.

In some embodiments, additional information is used in the processingstep 630 which can include, but is not limited to, heat-basedVCSEL-anti-device damage rules 681, heat-based tissue-anti-damage rules682, pulse-shaping rules 683, history of recent audio signals 686, andnerve response feedback information 619. Heat-based VCSEL-anti-devicedamage rules 681 may be used to limit how long, at what power level, andhow frequently a specific VCSEL is operated, in order to prevent damageto the VCSEL from overheating. Heat-based tissue-anti-damage rules 682may be used to limit how long, at what power level, and how frequently aspecific auditory nerve and/or surrounding tissue is illuminated, inorder to prevent damage to the nerve and tissue from overheating. Insome embodiments, where the channels are organized into bins, thetissue-anti-damage rules and the VCSEL-anti-device damage rules areapplied within each bin (set of adjacent frequency channels). In someembodiments, the rules can include limits as to the number of VCSELsoperated in a given bin at a single point in time or within a window oftime.

In some embodiments, the optical signal 696 emitted from the VCSELs istransmitted (function 697) to the auditory nerves, stimulating thenerves by triggering NAPS in the nerves (function 698). In someembodiments, optical detectors sense the nerve response (function 618),and the nerve responses are processed (function 619) to determine howthe person's auditory nerves responded to the optical-stimulationsignals. In some embodiments, the response information is fed back tothe channel-information-processing function 630, where this responseinformation is used to improve the channel processing and the driving ofthe VCSELs in order to improve the sound perceived by the person wearingthe cochlear implant.

In some embodiments, the programmed information-processor-storedinstructions and the various computer-readable data structures used bythe instructions, which are described above, are received (via function691 of FIG. 6A) from an external reprogramming device, allowing theoperation of the cochlear implant to be altered after theauditory-nerve-stimulation system has been implanted in a person.

Referring again to FIG. 6A, in some embodiments of method 601, at block610 an audio signal is obtained from one or more microphones configuredto obtain signals representing sounds and pressure variations in theenvironment surrounding the patient, and to generate electrical signalsthat are processed by process 612 to obtain real-time data representingeach of a plurality of audio-frequency channels, each audio-frequencychannel signal having a value based on the sounds within a limited bandof audio frequencies for the current time frame (or processing cycle).In some embodiments, the loudness values for the various audio-frequencychannels are processed by process 622 to select which audio-frequencychannels will be activated within each of a plurality of bins ofaudio-frequency channels, and a history of such values is stored byprocess 624 into data structure 686 (schematically shown in the adjacentgraph 687 of audio-frequency channel values, wherein graph 687 showspower of each audio-frequency channel on the vertical axis and centerfrequency of each audio-frequency channel on the horizontal axis). Insome embodiments, experimental rules for auditory stimulation arederived and a storage-medium having a general-rule computer-readabledata structure (CRDS) 684 contains general rules for mapping audio inputto auditory stimulation based on physiological considerations. Inaddition, some embodiments include a patient-specific CRDS 685 thatmodifies or supplements the general-rule CRDS 684. In some embodiments,patient-specific CRDS 685 is derived by empirically outputting a set ofaudio output signals to the implanted system and eliciting and receivingfeedback from the patient indicative of the sensations perceived as aresult of the optical and/or electrical stimulation applied. In someembodiments, operation 620, based on general-rule CRDS 684 andpatient-specific CRDS 685, derives a map of auditory input (e.g.,frequencies)-to-stimulation site(s) based on empirical testing andstores the resulting map into map CRDS 621. In some embodiments, foreach successive time frame, operation 622 combines the audio-frequencychannel-loudness-signal values from audio-processing operation 612 andthe mapping rules from CRDS 621 into audio-frequency channel-stimulationvalues. In some embodiments, operation 624 stores into CRDS 686 ahistory of the audio-frequency channel and/or bin values for most-recentP frames. Operation 630 then takes the audio-frequency channelinformation for the current time frame (and optionally from apredetermined number of prior time frames) and, using the heat-basedanti-tissue-damage-rules CRDS 682 (which limit the number ofaudio-frequency channels that are allowed to be activated in any onetime frame and/or within P successive time frames), along with data fromVCSEL heat-based anti-device-damage-rules CRDS 681 and rules forstimulation pulse shapes (pulse width and/or rise/fall shape) in CRDS683, operation 630 generates pulse parameters for the stimulation lightfor each VCSEL to be activated. Operation 695 takes the pulse parametersfrom operation 630 and drives the VCSELs to emit stimulation signals (aset of infrared optical-stimulation signal pulses and optionally one ormore electrical stimulation pulses) which are transmitted (function 697)to the tissue to trigger CNAPs. In some embodiments, the resultingphysiological response is a set of CNAPs 698 that is transmitted to thebrain of the patient, and operation 618 optionally measures the nerveresponse and operation 619 processes a feedback signal that is fed backinto operation 630. In some embodiments, a reloadable computer-readablestorage medium 690 holds instructions and data structures (in someembodiments, received (e.g., by a wireless receiver) 691 from anexternal device) that control the operations described above.

FIG. 6B is a flow chart of a method 602, according to some embodimentsof the present invention, for optimizing the pulse-repetition rate usedduring optical stimulation of the cochlea. In some embodiments, pulsedlight signals are generated at block 650, the generated light signalsare delivered to excitable tissue in a cochlea of a person to opticallystimulate the tissue such that NAPS are triggered at block 652, feedbackis elicited and received during (or shortly after) the delivery of thesignals at block 654, the delivery of the signals is empirically tested(to try to find the most effective pulse parameters) at block 656, (theabove-listed operations are iteratively repeated 662 in someembodiments), the most effective pulse-repetition rate for opticalstimulation is determined at block 658, and later, at block 660, duringnormal operation the signals are delivered to the excitable tissue basedon the pulse-repetition rate(s) determined to be most effective. In someembodiments, the normal operation of the device uses the different ratesthat are determined to be most effective for different frequency ranges(i.e., each audio-frequency channel or bin has its own most-effectiverate determined, stored and later used) or sound types (e.g., speechversus music).

FIG. 7 is a flow chart of a method 700, according to some embodiments ofthe present invention. The upper portion of this method 700 is similarto method 602 of FIG. 6B, except that the test sounds are customized toimprove the patient's enjoyment of music. Again, in some embodiments,pulsed light signals are generated at block 650 (now based on semitonemusical notes or other suitable sounds for music), the generated lightsignals are delivered to excitable tissue in a cochlea of a person tooptically stimulate the tissue such that NAPs are triggered at block652, feedback is elicited and received during (or shortly after) thedelivery of the signals at block 654, the delivery of the signals isempirically tested for effectiveness in providing semitone sensations atblock 656, (the above-listed operations are iteratively repeated 662 insome embodiments). At block 730, the most effective one or more VCSELsfor optical stimulation are determined, and later during normaloperation at block 735, the signals are delivered to the specific areasexcitable tissue from the selected VCSELs based on the VCSELs determinedto be most effective for semitones or other musical features (e.g., manydifferent frequencies for snare drum sounds). In some embodiments,different locations are most effective for different musical types(i.e., each musical type may benefit from selecting VCSEL channels(i.e., selecting from among the set of all optical-stimulation channels)for each music feature differently; these maps of music-to-VCSELmappings are stored and later used). In some embodiments, eachaudio-frequency channel uses one or more optical-stimulation channels(i.e., one or more emitters that stimulate a corresponding number ofareas of the cochlea) to create a perceived sound sensation associatedwith the frequencies within the audio-frequency channel. In someembodiments, a large number of emitters are implemented in the implanteddevice and the calibration process selects, from among the totalavailable emitters, one or more of those that are best suited for aparticular hearing environment (e.g., speech versus music listening),and that are then to be used for each of the plurality of perceivedsound sensations of that environment.

FIG. 8A is a flow chart of a method 800, according to some embodimentsof the present invention. Method 800 is described below.

FIG. 8B is a graph of a binned-channel-with-history spectrum 802,according to some embodiments of the present invention. This graph showsa plurality of audio-frequency channels having current power levels 824and an indication of recently-past power levels 825. Each one of theplurality of audio-frequency channels is also assigned into one or morebins 812.1-821.N—in the embodiment shown the bins include a plurality ofoverlapping bins (note that the right-most two audio-frequency channelsof bin 812.1 are the left-most two channels of bin 812.2, and so on).

Referring to FIG. 8A, at block 805, an audio signal having an audiospectrum is obtained. At block 810, the audio signal is processed into Maudio-frequency channels for each of a plurality of successive timeframes. At block 815, a subset of up to N audio-frequency channels areselected from the original M channels for the current time frame, basedon how many audio-frequency channels are the most active in each bin andoptionally how many of those channels or of nearby channels wereactivated in the recent past. At block 820, one or more pulses ofoptical-stimulation light are generated for each of the selected Nchannels active for this time frame. At block 825, the light isdelivered to the excitable tissue.

FIG. 9 is a flow chart of a method 900, according to some embodiments ofthe present invention. The upper portion of this method 900 is similarto method 602 of FIG. 6B, except that the test optical-stimulationparameters are customized to improve the effectiveness of various valuesto provide a sensation of loudness having an increased dynamic rangeand/or to achieve some other hearing or comfort goal. Again, in someembodiments, pulsed light signals are generated at block 650 (now havinga parameter such as optical spectrum, pulse power, or other parameterbeing varied), the generated light signals are delivered to excitabletissue in a cochlea of a person to optically stimulate the tissue suchthat NAPs are triggered at block 652, feedback is elicited and receivedduring (or shortly after) the delivery of the signals at block 654, thedelivery of the signals is empirically tested at block 656 foreffectiveness in providing a sensation of loudness having an increaseddynamic range and/or achieving some other hearing or comfort goal, (theabove-listed operations are iteratively repeated 662 in someembodiments). In some embodiments, the empirical testing 656 determinesa plurality of parameters that are, as a whole, most effective (e.g.,sometimes this produces a compromise between parameters that need to bedifferent for different environments). At block 925, the most effectiveparameter(s) for optical stimulation are determined, and later duringnormal operation at block 930, the optical-stimulation signals aregenerated using the parameter(s) determined here to be most effectivefor delivering the hearing perception desired. In some embodiments,different parameters are most effective for different speech or musicaltypes (i.e., each musical type may benefit from selecting a differentset of parameters, and these mappings are stored and later used).

FIG. 10 is a flow chart of a method 1000, according to some embodimentsof the present invention. The upper portion of this method 1000 issimilar to method 602 of FIG. 6B, except that the test sets a peak powerand a repetition rate at preset values and varies the pulse-widthoptical-stimulation parameter (and thus varies the energy amount of eachpulse) in order to improve the effectiveness of various pulse-widthvalues to provide improved perceived dynamic range of loudness. Again,in some embodiments, pulsed light signals are generated at block 650(now having a parameter such as pulse width being varied), the generatedlight signals are delivered to excitable tissue in a cochlea of a personto optically stimulate the tissue such that NAPs are triggered at block652, feedback is elicited and received during (or shortly after) thedelivery of the signals at block 654, at block 1020, the pulse width isvaried while maintaining peak power and repetition rate fixed, and theeffectiveness of various different pulse widths to give differentloudness perception is empirically tested at block 1025, (theabove-listed operations are iteratively repeated 662 in someembodiments). At block 1025, the signals are delivered and at block 1030the most effective parameter(s) for optical stimulation are determined,and later during normal operation at block 1035, the optical-stimulationsignals are generated using the parameter(s) determined here to be mosteffective for delivering the hearing perception desired.

FIG. 11 is a diagram the firing of auditory nerve cells 1100 as haircells are deflected. In some embodiments of the present invention,perceived loudness of sounds is varied by changing theauditory-nerve-stimulation rate. In normal hearing physiology, as soundpressure increases, hair cells 1100 are further deflected and actionpotentials are fired at greater rates (linear relation). Graph 1110shows the amount of deflection of hair cells 1100. Graph 1120 shows theaction potential firing rates corresponding to the differing amounts ofhair-cell deflection shown in graph 1110. By varying the stimulationrate, one can convey loudness. The greatest sustainable firing rate(saturation) is about five-hundred (500) spikes per second (Kandel,2000).

FIG. 12 is a graph 1200 of auditory nerve firing rate versus sound levelfor acoustically stimulated hearing (i.e., nerve signals from normalhearing in contrast to nerve signals from electrical or opticalstimulation of the nerve(s)). Increasing sound intensity causes the peakof basilar membrane vibrations to get bigger, stimulating both inner andouter hair cells (ihc/ohc) more. Increased stimulation of the hair cellscauses increased auditory nerve firing rates, as shown in 1200. Theresponse of the outer hair cells grows rapidly with increasing intensityat low intensities, but more slowly at higher intensities (compressive).A wide dynamic range is accomplished by this compressive response and bythe effect of low- and high-threshold neurons. Low-threshold neuronssaturate at low-to-mid sound levels. High-threshold neurons becomeactive at higher sound intensities, and saturate at higher soundintensities.

FIG. 13 is a graph 1300 of auditory nerve firing rate versus soundlevel. Electric current stimulates the auditory nerve fibers in thecochlea, producing action potentials that are conducted to the brain.However, with direct auditory nerve stimulation without the inner haircells, the nerve fibers differ in threshold only slightly, so thedynamic range of the combined response is much like the response of asingle nerve fiber. The result is a steepening of the combinedfiring-rate curve for electrically stimulated nerves as compared toacoustically stimulated nerves, shown in 1300.

FIG. 14 is a graph 1400 of perceived sound level versus auditory nervefiring rate. If one considers perceived loudness as being driven byauditory nerve firing rate (stimulation rate), the graph shows thatloudness (intensity) is a weak function of firing rate: even a largechange in firing rate generally results in a small change in perceivedloudness. Many papers seem to indicate that perceived loudness is a weakfunction of stimulation rate in electrical and optical stimulation,including McKay (1998), Vandali (2000), and Littlefield (2010).

FIG. 15 is a set of graphs 1500 (McKay, 1998) of test subject loudnessperception at differing electrical-stimulation pulse rates. As describedin McKay (1998), cochlear-implant listeners were asked to balanceloudness between a test signal at a number of stimulation rates versus areference signal at a 50-pulses-per-second (pps) stimulus rate. As theperceived loudness of the test signal increased at increasingstimulation rates, the test subjects reduced the strength of the testsignal to keep its perceived loudness equal to that of the referencesignal. It is clear that, at comfortably loud levels, subjects reducedthe strength of the test signal by relatively small amounts (less than 2dB) over a large range (1000 pps) of stimulation rates. These testresults show that increasing auditory-nerve-stimulation ratessignificantly, results in only small increases in perceived loudness ofsounds.

FIG. 16 is a set of graphs 1600 (McKay, 1998) of test subject averageauditory nerve spike probability versus stimulation rate. As describedin McKay (1998), the small increases in perceived loudness withincreasing stimulation rate are most likely a result of auditory nerveaction potential spike probability dropping with increased stimulationrate, which has been observed in optical stimulation (Littlefield,2010). The data in 1600 show a drop after 100 pps.

FIG. 17A and FIG. 17B are graphs (Vandali, 2000) of signal current levelfor various auditory-nerve-stimulation rates. FIG. 17A presents datafrom Test Subject 1; FIG. 17B presents data from Test Subject 3. In anexperiment described in Vandali (2000), cochlear-implant listeners setcurrent levels for all electrodes in their cochlear implant for threedifferent stimulation rates. In these graphs, current level units areclinical units (that use a 2% increase per step). The tests wereconducted at various sound levels, including threshold (t-level) andmaximum comfortable loudness (c-level). It is clear that stimulationrate did not affect loudness settings significantly. There is only anapproximately 1-2 dB variation in perceived signal loudness at thedifferent stimulation rates (which varies with subject).

FIG. 18A is a graph 1801 of action potential rates versus frequency foracoustically stimulated nerves, FIG. 18B is a set of graphs 1802 of thedistribution of numbers of neurons versus frequency, FIG. 18C is a graph1803 of nerve action potential response rate versus stimulation rate,and FIG. 18D is a graph 1804 of nerve-firing efficiency versusoptical-stimulation rate, all of which show experimental data presentedin Littlefield (2010). In experiments described in Littlefield (2010),single auditory nerves of normal-hearing gerbils were first acousticallystimulated, and recordings were made from 403 neurons. The centerfrequencies of the stimulation sounds were between 118 Hz and 22 kHz.1801 is a graph of the maximum action potential rates versus stimulationfrequency for the observed neurons. The average maximum action potentialrate was 158±82 (158 plus-or-minus 82) action potentials per second.Graph A 1802 in FIG. 18B shows the number of neurons (i.e., how many)that responded to each frequency.

Two diode lasers were then used for stimulation of the auditory nerves.They operated between 1.844 μm and 1.873 μm, with pulse durations of 35μs to 1,000 μs, and at repetition rates up to 1,000 pulses per second(pps). The laser outputs were coupled to a 200-μm-diameter optical fiberplaced against a round window membrane and oriented toward the spiralganglion and at a distance 0.5 mm from the spiral ganglion in the basilturn. Neural activity was recorded for different laser radiantexposures, pulse durations, and stimulus-repetition rates. Therecordings were taken from 154 single neural fibers, 67 of which showedstimulation responses. 1802 graph B shows the number of neurons thatresponded to the optical stimulation plotted against theircharacteristic frequencies: 67 neurons having characteristic frequencieswith a range of 450 Hz to 20 kHz responded. 1802 graph C shows thenumber of neurons that did not respond to the optical stimulationplotted against their characteristic frequencies: 87 neurons havingcharacteristic frequencies with a range of 148 Hz to 10 kHz did notrespond to the optical stimulation. Graph 1803 in FIG. 18C shows theaction potential firing rate versus the auditory-neuron-stimulationrate. The number of evoked action potentials is fairly flat asstimulation rate is increased. It can be seen that the laser-evokedresponse rates were lower than with acoustic stimulation. The averagemaximum action potential rate was 97 plus-or-minus 53 action potentialsper second. Graph 1804 in FIG. 18D, which plots neuron firing efficiencyversus stimulation rate, shows that firing efficiency drops after 100pulses per second (pps).

FIG. 19 is a graph 1900 (Fu et al., 1999) of phoneme recognition as afunction of stimulation rate in six Nucleus-22 cochlear implantlisteners. In some embodiments of the present invention, loudness isencoded in stimulation rate. Data from Fu et al. (1999) indicates thatspeech recognition requires repetition rates (auditory-nerve-stimulationrates) at least about 150 pulses per second (pps). A damage thresholdmay limit pulse-repetition rates to no more than about 300 pps (personalcommunication from Claus-Peter Richter, Northwestern University, asometime collaborator of the inventors). For an optical-stimulation ratein the range of 150-300 pps, a less than 2 dB dynamic range is expected.

FIG. 20 is a graph 2000 (Fu et al., 2000) of phoneme recognition as afunction of stimulus dynamic range of the electrical stimulus of acochlear implant. The data from Fu et al. (2000) in the graph arepercent correct phoneme recognition rates for 3 test subjects. Consonantand vowel phonemes were tested separately, and tests were conducted atthree different signal-compression levels, p=0.1 (high), p=0.2 (medium)and p=0.4 (low). In some embodiments, the design is based on the dynamicrange needed. The data from Fu et al. (2000), graph 2000, shows that thestimulus dynamic range should be at least 5-10 dB. It has been shownthat the loudness of an electrical stimulus in microamps (pA) isanalogous to the loudness of an acoustic stimulus in dBs. Loizou (2006)showed that a 5-dB dynamic range is sufficient for phoneme recognition,and that electrical-stimulation cochlear implants provide at least a5-dB-stimulus dynamic range. Nelson (1996) showed that cochlear-implantlisteners perceive seven to forty-five (7-45) sound-intensity steps. Fuand Shannon (Fu et al., 2000) showed that phonetic discrimination dropswhen the dynamic range is less than 6-to-8 dB.

Using Both Optical and Electrical Stimulation in a Cochlear Implant

In some embodiments, the present invention provides an apparatus andmethod in which one or more electrical-stimulation electrodes areincluded at the apical end of the cochlear implant and used to evoke anauditory sensation corresponding to low-audio-frequency content of thesound in the environment, which is especially helpful in speechrecognition. As noted above, in conventional electrical-only cochlearstimulation, one challenging problem is the spreading of the electricalsignal through the conductive fluid and tissue in the cochlea. Opticalstimulation does not suffer this problem and therefore has an advantagein its ability to stimulate in a more specific manner, which leads tohigher spectral fidelity for the implantee. A challenge arises, however,to stimulate the apical spiral ganglion cells which sense sound signalsat the lower frequency range (e.g., in some embodiments, less than about250 Hz) because the size and shape of the implant does not readily reachthe apical end of the cochlea's openings (e.g., the larger of thesecochlear channels, the scala tympani, is typically used for the implant)there is no spreading of the optical signal to illuminate and stimulatethe cells beyond the tip of the implant, deep in the cochlea.Conventional electrical stimulators inserted to the same depth canaccess these deeper regions because of the spread of electricity reachesnerves deeper into the cochlea. In some embodiments of the cochlearimplant device of the present invention, twenty-two (22) audio-frequencychannels (or other suitable number of audio-frequency channels) areselected from a set of at least that many total emitters of the deviceand used for optical stimulation (these selected ones are sometimescalled the active optical-stimulation channels for sound sensations tobe perceived by the user and in some embodiments, are selected from aset of many more available emitters in the device by empirical testingto determine the ones that are most effective at each perceivedfrequency) along the implantable region within the cochlea and one ormore electrodes are used at the deepest apical end of the implant tostimulate beyond the end of the implant. This additionalelectrical-stimulation channel (or electrical-stimulation channels eachof which corresponds to one or more audio-frequency channel) providesimproved low-audio-frequency sensations for the high spectral fidelitydelivered by the optical stimulation from 6000 Hz down to the deepestimplantable region (about 250 Hz), by additionally providing stimulationdeeper in the cochlea by one or more electrodes at the end of theimplant.

As used herein, an “audio-frequency channel” is the signal and/or valuerepresenting audio power within a narrow band of audio frequencies, andeach “audio-frequency channel” refers to the entire path from the audioprocessor to the optical-stimulation signal launched towards the cochleaneural tissue for its frequency band. The audio processor “dissects” thefull spectrum of the input audio (e.g., using a fast-Fourier transform(FFT), discrete cosine transform (DCT) or other suitable algorithm ormethod) into a plurality of frequency bands (used for the respectiveaudio-frequency channels), each representing content of audio powerwithin a predetermined range of audio frequencies. An“audio-frequency-channel bin” is a group of adjacent audio-frequencychannels that forms one of a plurality of subsets of the full set ofaudio-frequency channels. In some embodiments, audio-frequency-channelbins overlap with one another; for example, the firstaudio-frequency-channel bin may include only audio-frequency channels1-5, the second audio-frequency-channel bin may include only channels4-8, the third audio-frequency-channel bin may include only channels7-11, and so on (such that audio-frequency channels 4-5 are included inboth bin 1 and in bin 2 (such that bin 1 and bin 2 overlap by twoaudio-frequency channels), while audio-frequency channels 7-8 areincluded in both bin 2 and in bin 3 (such that bin 2 and bin 3 overlapby two audio-frequency channels), but bin 1 and bin 3 do not overlap andaudio-frequency channel 6 is not included in either bin 1 or bin 3. Inthis way, the method of the present invention can prevent simultaneousactivation of two or three of any three adjacent audio-frequencychannels during a single time frame or a time period having apredetermined number of P (e.g., two or more) successive time frames.The variable “M” represents the number of channels in the full set. Thevariable “N” represents the maximum number of channels in the subset ofchannels that are allowed to be activated at a given time. The value ofN may vary over time—e.g., N may have a larger value after a time periodthat had a continued low level of audio, but may have a value thatstarts small and gradually increases over time after a period of verylow (quiet) audio in order not to jolt or overstress the auditoryportion of the patient's brain, and may have a value that graduallydecreases over time after a period of very high (loud) audio that mayhave caused heat build-up in one larger localized area (i.e., an areathat is the destination of two or more optical-stimulation channels) ofthe cochlea, or in the cochlea as a whole. In addition, in someembodiments, as described herein, the up-to-N channels that are selectedfor activation in a given time period are selected so as to spread outthe area over which stimulation light is applied so as to avoidoverheating small or localized areas in the cochlea. The term “frame” or“time frame” is the smallest quantum of time in which audio power isdivided by the software and/or control electronics of the presentinvention for the purposes of limiting heat buildup, and in variousembodiments each frame may be about 4 milliseconds (which results in 250frames per second) to about 7 milliseconds (which results in about 141samples per second). In some embodiments, a running history of the mostrecent H values in each channel and/or each bin is maintained, allowingthe method of the present invention to also limit the number of timesany one channel or group of channels may be activated within Hsuccessive time frames.

Optimizing the Pulse-Repetition Rate of an Optical Cochlear Implant

Limitations on the upper limit of optical-stimulation pulse-repetitionrate exist for optical-stimulation devices—limitations that are based ondeleterious heating effects in the cochlea. However, speech recognitionis also based on stimulation rate, and often benefits from a higherstimulation pulse-repetition rate. In some embodiments of the presentinvention, stimulation rate (i.e., pulse-repetition rate) is optimizedfor the patient based on comfort levels, speech-recognition scores, andtemperature feedback from monitors in the cochlea. Thus, in someembodiments, the methods of the present invention find practical lowerand upper limits to the rate of stimulation to increase thespeech-recognition scores while implementing safety limits to preventingoverheating. In some embodiments, stimulation is optimized for speechrecognition and is kept above 150 pulses per second (pps), based onfindings that speech recognition degrades below 150-ppspulse-repetition-rate-per-channel (see, e.g., Qian-Jie Fu and RobertShannon, “Effect of Stimulation Rate on Phoneme Recognition byNucleus-22 Cochlear Implant Listeners,” J. Acoust. Soc. Am. 107, pp589-597 (1999)). In some embodiments, pulse-repetition-rate optimizationis performed by determining the number of stimulation channels that canbe simultaneously stimulated at a given pulse-repetition rate. In otherembodiments, pulse-repetition-rate optimization is performed bydetermining the pulse-repetition rates to use per channel.

Loudness perceived by a patient is a weak function of stimulation rate.Optical stimulation is limited to 150-to-300 pulses-per-second (pps)range. In some embodiments, a stimulation rate of at least 150 pps isrequired for speech recognition. In some embodiments, a stimulation rateof no more than 300 pps is required to stay below the damage threshold(e.g., the pulse-repetition rate that risks damage from heating thetissue being optically stimulated or nearby tissue). This range ofpulse-repetition rates only allows less than 2 dB of loudness dynamicrange. Further, some experiments have shown firing efficiency dropssignificantly with a stimulation pulse-repetition rate over 100 pps, andthe action potential rate plateaus after about 50-100 pps. Little or nospeech information can be conveyed through a stimulation rate belowabout 100 pps. This is not sufficient for improvement over currentelectrical stimulation. Therefore, some embodiments encode loudnessinformation in the pulse width of the optical pulses used forstimulation.

Additionally, in some embodiments, stimulation rate is kept below a ratewhich overheats the cochlea. In some embodiments, a temperature monitoris placed inside the cochlea to monitor and feedback a temperature foruse in limiting the stimulation rate and/or other parameters such aspeak optical power, wavelength, and pulse width. In other embodiments,the temperature of the cochlea is modeled. Additionally, in someembodiments, the temperature monitor serves as a feedback to a safetyshut-off switch in the case of overheating. Further, in someembodiments, the present invention provides a patient-activatableelectromagnetic emergency-off mechanism.

In some embodiments, the implanted device 110 includes a “fail-safe”circuit 588 (see FIG. 5) that immediately (or after a shortpredetermined amount of time) turns off all stimulation devices(including lasers or other optical sources, as well as theelectrical-stimulation drivers) if and when communications are lost tothe externally worn device 111. In this way, if excess loudness or otherdiscomfort is perceived, the patient can simply remove the externallyworn device from their body and move it to a distance far enough awayfrom the implanted device that the wireless communications isdisconnected, in order to actuate the fail-safe circuit 588. In someembodiments, the externally worn device 111 periodically transmits aperiodic “heart-beat” signal that, as long as it is detected (withineach successive time period of a predetermined duration) by thefail-safe circuit 588, prevents the fail-safe circuit 588 from turningoff all stimulation devices, but once a predetermined amount of timepasses in which no “heart-beat” signal is detected, the fail-safecircuit 588 turns off all stimulation devices.

In some embodiments, the present invention provides an apparatus andmethod in which the stimulation rate is optimized for the patient basedon comfort levels, speech-recognition scores, and temperature feedbackfrom monitors in the cochlea. Stimulation can be optimized for speechrecognition and should be kept above 150 pulses per second (pps) basedon findings that speech recognition degrades below a 150-pps perchannel. Additionally, stimulation rate should be kept below a rate thatwould overheat the cochlea. In some embodiments, one or more temperaturesensors or monitors are placed inside the cochlea to monitor and providefeedback signals indicative of temperature for use in limiting thestimulation rate and/or other parameters, such as peak optical power,wavelength, and pulse width. Additionally, in some embodiments, thetemperature monitor generates a feedback signal to a safety shut-offswitch in the case of overheating. This problem is new, as opticalstimulation of the cochlea is new. In some embodiments, the apparatusincludes a patient emergency-off switch (e.g., electro-magnet inexternally worn device transmits a periodic signal through the skin tokeep the implant active). When patient removes externally worn devicefrom the head, the implant no longer receives the periodic signal andturns off the stimulation signals).

Providing Enhanced Music Perception in an Optical Cochlear Implant

Patients having conventional electrical cochlear implants usually do notenjoy the perception of music, as the electrical stimulation cannotspecifically excite the regions of the cochlea that tonotopicallyrepresent the semitones of Western music. It would be nearly impossibleto place the electrodes exactly at the semitone locations. Further, evenif the electrodes were placed directly over the semitone regions, theelectrical signal would spread too much to specifically excite theregions of interest. The use of optical sources to deliver light to thecochlea for purposes of stimulation brings the advantage of increasedspectral fidelity because the illumination can be more specificallyplaced than electrical signals.

In some embodiments, a large plurality of light sources orlight-delivery devices are placed along the cochlea, but only arelatively small fraction of them are used due to the limitation ofpower delivery and a restriction on heat within the cochlea. The largenumber of implemented emitters also allows selection of the bestpositions for stimulation without a priori knowledge of the exactplacement, since the device can be tested, calibrated and optimized topick the best emitters that most exactly stimulate the desiredlocations, and periodically repeat this process to reprogram andrecalibrate the device. The ability to choose the sources used furtherprovides the ability to choose the sources which illuminate thesemitones found in Western music. This ability to access the exactplaces in the cochlea where semitones are psychophysically representedwill improve musical perception in the patient.

In one embodiment, a plurality of light sources are connected through aseries of fuses that can be “blown” to permanently disconnect thosedevices that are not to be used, and thus select the desired source(s)in the region of interest. In other embodiments, similar to aprogrammable logic array, the logic is programmable and settable duringoptimization of the device for the patient, and optionallyreprogrammable and re-settable during a later re-optimization. In someembodiments, optical stimulation optimized, or at least improved, formusic perception is a user-selected mode of the cochlear implant. Insome such embodiments, optimization for music perception is one of aplurality of user-selected modes. In some embodiments, music-perceptionoptical stimulation uses “N-of-M” signal coding, as described below. Inother embodiments, the sources selected to be used are re-programmablyor dynamically (i.e., non-permanently, reprogrammably, and/or in amanner that changes over time) activated according to a stored table orother mechanism within the implant and/or the externally worn device(e.g., a device having a microphone, some audio-processing capabilityand a wireless transmitter that transmits (to the implanted device)information corresponding to the microphone-sensed audio).

In some embodiments, an audio processor analyzes the incoming audiosignal from the microphone or other input device and makes adetermination as to the content of the signal, that is, whether theaudio signal is primarily speech, or primarily music. In someembodiments, one or more of the regions of the cochlea that arestimulated are automatically changed to optimize either music perceptionor voice perception, based on the device detecting primarily voice orprimarily music content in the received audio. In other embodiments, amusic-perception stimulation mode is selected, from one of a pluralityof listening modes, by the wearer of the implant manually activating anelectrical switch, a magnetic trigger, an accelerometer configured todetect a tip of the head of the wearer, or other input device on theexternal portion of the implant system. In some embodiments, thefrequency range stimulated in the cochlea can be changed depending onthe type of audio signal being received. In some embodiments, both thebandwidth of the processed signal and the pitch range are dynamicallyaltered based on the listening mode (whether the mode is automaticallyselected or user selected). In some embodiments, the incoming audiosignal is processed in a way that shifts the nerve regions beingstimulated (analogous to shifting the audio in frequency (higher orlower)) to nerve regions that work better (or that are sensed to be moreenjoyable) for music perception.

In some embodiments, “semitone” is defined to mean the interval betweenadjacent notes in the twelve-note equally tempered scale. The frequencyratio between two adjacent semitones is 2̂(1/12) (the 12^(th) root oftwo):

(Frequency of Semitone N)/(Frequency of Semitone N−1)=12^(th) root oftwo (Eqn. 1)

The twelve-note equally tempered scale is commonly used in Westernmusic. In other embodiments, the “semitone” for adjacent notes is basedon other scales or tunings which do not have equal ratios betweensemitones, or which use a scale having equal ratios between notes buthaving other than twelve notes. Examples of these other tunings includethe historic Pythagorean Tuning, and Just Intonation commonly used by Acappella groups.

The objective in calibrating a cochlear implant to a specific individualis to achieve pleasurable perception and/or improved recognition ofmusic. Causing the patient wearing the implant to perceive the actualfrequencies in a music source is not necessary. To enhance theperception of music, the intervals between notes (musical pitches),being played either simultaneously or successively, must be correctlyperceived by the patient. Intervals (the frequency difference) betweennotes can be characterized as an integral number of semitones. There aremultiple definitions of “semitone” depending on, for example, type ofmusic, historic time period of music, type of musical instrument, andmusical culture (e.g., oriental versus western). Therefore, a cochlearimplant in a particular patient is calibrated so musical intervals soundpleasing to that individual.

In some embodiments, calibration of an implant is performed as follows.This particular method is analogous to a plano-tuning method describedby Fischer (1907/1975) in “Plano Tuning” An initial musical pitch ischosen from which to perform the calibration. In some embodiments, theinitial pitch is a C4 frequency (commonly known as middle C) as thatpitch would be extracted from received audio signal of music. In otherembodiments, the initial pitch is C5 (the C one octave middle C). Inother embodiments, some other initial pitch is used. In the followingdescription of one embodiment, an initial pitch of C4 is used. Anoptical-stimulation channel is assigned to C4 such that theoptical-stimulation channel triggers nerves in the cochlea near theregion of the cochlea that responds to the C4 pitch. See Omran (2011),“Semitone Frequency Mapping to Improve Music Representation for NucleusCochlear Implants” for a description of mapping particular frequenciesto locations along the basilar membrane. Next, an initialoptical-stimulation channel is assigned to the pitch C5 that stimulatesnerves in the cochlea near the region of the cochlea that responds toC5. Again, from Omran (2011) an approximate location along the basilarmembrane can be determined. A C4-pitched tone and a C5-pitched tone areplayed for the patient whose cochlear implant is being calibrated, andthose tones are received and processed into optical-stimulation output,wherein in some embodiments, the two tones are played simultaneously(two cochlear areas stimulated simultaneously), and then are alternated(the two cochlear areas stimulated alternately). As the C4 and C5 tones(simultaneous with one another and/alternating with one another) arereceived and decoded, the optical-stimulation channel selected for C4 isexcited/operated, and the initial C5 site excited by the initialoptical-stimulation channel, and one or more alternate “C5” sites andoptical-stimulation channels near the one initially assigned to thepitch C5 are excited/operated to “play” the C5 tone to the patient.Stimulation of stimulation sites that are not quite “an octave apart”may be perceived as discordant or unpleasant by the patient. The patientis asked to choose which optical-stimulation channel provides thepatient with the best perception of two tones separated by an octave(sites that cause the most pleasant or least discordant or unpleasantsensation), and this optical-stimulation channel is assigned to thepitch C5. A corresponding procedure is then repeated for the C3 pitch(stimulating the C4 site and sites around an initial C3 site).

With octave pitches assigned to specific optical-stimulation channels,the rest of the musical pitches are then calibrated. An initialoptical-stimulation channel is assigned (see Omran, 2011) for the G3pitch (G a musical fifth (5 semitones) above C3). An interval of a fifthis used because most individuals, even those with no musical trainingcan identify a fifth: musically, it sounds pleasant (it is perceived aspleasant). As in assigning optical-stimulation channels to the octavepitches, C3 and G3 pitched tones are played (simultaneously and/oralternately) for the patient. Optical-stimulation channels near the oneinitially chosen for G3 are used to “play” the G3 tone, and patientfeedback used to assign the optical-stimulation channel that provideshim or her with the most pleasant sensation (hopefully, the bestperception of a musical fifth). The octave-determining process isrepeated for the G4 pitch (using the G3 site and a plurality of sites tolocate one for G4 that is best perceived as an octave above G3). In someembodiments, as a check, a G4 pitched tone is played with a C4 pitchedtone (a musical fifth interval), and the optical-stimulation channelassigned to G4 slightly adjusted so that both octave interval (above G3)and the fifth interval (above C4) both sound most pleasant to thepatient. The process is repeated for other pitches in the musical scale,doing D4 (a fifth above G3) next, then D3 (an octave below D4, and soon. In some embodiments, the calibration is done using only intervals ofoctaves and fifths, which are easy for most people to recognize. In someembodiments, where the cochlear implant has an extended frequency range(more than 2 octaves), the above process is repeated to extend theperceived musical range. In other embodiments, additional or alternativemusical intervals are used (such as musical thirds and/or sevenths). Insome embodiments, an additional process is used to identify a best setof immediately adjacent semitones, wherein two adjacent semitones arediscerned as discordant when played simultaneously, but a scale of 8 or12 successive notes is perceived as “equally tempered” by the patient.In some embodiments, the entire process or portions thereof isiteratively repeated to fine tune the perception of an equally temperedscale and harmonies formed from such a scale. In some embodiments, asuccession of chords of two or more simultaneous notes is played tofurther fine tune the patient's perception of music.

In other embodiments, calibration of the cochlear implant is performedby initially assigning optical-stimulation channels to all pitches, forexample, using the mathematics described in Omran (2011):

-   -   Equation 2 below describes the characteristic frequencies at        distance x mm from the cochlea's apex according to Greenwood's        empirically derived function which was verified against data        that correspond to a range of x from 1 to 26 mm [12].

$\begin{matrix}{{f(x)} = {165.4\left( {10^{0.06x} - 1} \right)}} & (2) \\{\left. \Rightarrow{x(f)} \right. = {\frac{1}{0.06}{\log \left( {\frac{f}{165.4} + 1} \right)}}} & (3)\end{matrix}$

-   -   The distance (in mm) between two locations with different        characteristic frequencies f₁ and f₂ is given by Equation 4

$\begin{matrix}{{\Delta \; x} = {{x_{2} - x_{1}} = {\frac{1}{0.06}{\log \left( \frac{f_{2} + 165.4}{f_{1} + 165.4} \right)}}}} & (4)\end{matrix}$

In some embodiments, after the initial assignment of optical-stimulationchannels, easily recognizable pieces of music are played for thepatient. A music-recognition score, based on feedback from the patient,is used as a guide in fine tuning the assignment of optical-stimulationchannels to specific pitches.

In some embodiments, the present invention provides an apparatus andmethod in which optical sources deliver light to small specific areas ofthe cochlea for purposes of stimulation, which brings the advantage ofincreased spectral fidelity (fine-grained audio frequency perceived bythe patient) because the stimulation illumination can be morespecifically placed than electrical-stimulation signals. Conventionalelectrical-stimulation-only cochlear-implant patients often do not enjoythe perception of music, as the electrical stimulation cannotspecifically excite the regions of the cochlea that tonotopicallyrepresent the semitones of Western music. It would be nearly impossibleto place the electrodes exactly at the semitone locations in thecochlea. But, even if the electrodes were placed directly over thesemitone regions, the electrical signal would spread too much tospecifically excite the regions of interest. In some embodiments of thepresent invention, a plurality of light sources or light-deliverydevices are placed at finely-spaced locations along the cochlea, butonly a fraction of them are used within any short period of time due tothe limitation of power delivery to the optical emitters and arestriction on heat within the cochlea due to the absorption of theoptical-stimulation signals. The ability to choose which optical sourcesare used at any given time frame provides the ability to choose thesources that illuminate and thus stimulate the particular small areas ofthe cochlea that generate nerve signals perceived as the semitonefrequencies found in Western music. This ability to access the exactplaces in the cochlea where semitones are psychophysically representedwill improve musical perception by the patient. In one embodiment,multiple sources are connected through a series of fuses that can be“blown” to select the desired source in the region of interest. Similarto a programmable logic array, the logic could be programmable andsettable during optimization of the device for the patient. In otherembodiments, the sources selected to be used are re-programmably ordynamically (i.e., in a manner that changes over time) activatedaccording to a stored table or other mechanism within the implant and/orthe externally worn device (e.g., a device having a microphone, someaudio-processing capability and a wireless transmitter that transmits(to the implanted device) information corresponding to themicrophone-sensed audio.

Encoding Information in an Optical Cochlear Implant for Minimal HeatEffects

In electrical stimulation, the challenging problem is the spreading ofthe electrical signal through the conductive fluid and tissue in thecochlea. Optical stimulation does not suffer this problem and thereforehas an advantage in its ability to stimulate in a more specific manner,which leads to higher spectral fidelity for the implantee. Onechallenge, however, is heating of the tissue by the optical channels.Because the physiological mechanism for stimulation using opticalsignals is thermal, careful engineering is needed to allay thermalbuildup in the cochlea. In some embodiments, signal-coding strategiesare used to reduce the number of channels on at any given time andtherefore reduce the average power delivered and heat produced. In someembodiments, a commonly used coding strategy is the “N-of-M” codingstrategy, where the input frequency spectrum is analyzed by the signalprocessor and spectral power is dissected into M channels, then, bysubsequently determining the N channels with the highest power, thosechannels are stimulated by the corresponding electrodes in the implant.In some embodiments, this is done frame by frame, where the frame rateis the refresh rate of the data processor (in some electrical cochlearimplants, this is done for the reason that electrical implantees cannotutilize more than 8 channels due to electrical spread in the cochlea).

In some embodiments, an N-of-M coding strategy is used, while placing aquota on the number of channels selected to illuminate in each frame.Speech tends to fill the audio frequency spectrum between 50-6000 Hz andconventional electrical-stimulation cochlear implant speech processorstend to cover the range 240-6000 Hz, depending on insertion depth. Insome embodiments of the present optical-simulation cochlear-implantinvention, an audio range of 50-6000 Hz or other suitable range is used,wherein this total audio range is broken into 22 (or other suitablenumber of) audio-frequency channels and 11 (or other suitable subsetnumber of) these audio-frequency channels are illuminated at eachtime-frame cycle (sometimes simply called “frame” herein). In otherembodiments, rather than simply illuminate the 11 frequency-basedchannels of the detected audio spectrum having the highest power duringa given time-frame cycle, there is a quota to illuminate at least Xchannels from each bin of channels (wherein, in some embodiments, forsome bins, X is zero or more, while for other bins, X may be one, two,or more channels) and no more than Y channels from each bin. This limitsthe number of illuminated channels-per-length of cochlea and thereforeprevents localized heating of the cochlea and reduces power consumptionof the device. In some embodiments, rather than using non-overlappingbins (wherein the lowest-frequency channels of one bin could becontiguous with the highest-frequency channels of an adjacent bin),overlapping bins are used, such that the Y limit on channels (i.e., howmany channels in one bin that are allowed to be active in a givenpredetermined period of time) applies to adjacent areas that might havebeen in different bins if non-overlapping bins were to be used.

In some embodiments, the present invention provides an apparatus andmethod in which a subset of N frequency-based stimulation channels areselectively activated from a set of M measured frequency-based audiovalues (N-of-M coding) for each given time frame. One coding strategyused in conventional electrical-stimulation cochlear implants is anN-of-M coding strategy, where the input frequency spectrum is analyzedby the signal processor and spectral power is dissected into Mfrequency-based channels, then, by subsequently determining the Nchannels with the highest power, those channels are activated tostimulate the corresponding electrodes in the implant. This is doneframe by frame, where the frame rate is the refresh rate of the dataprocessor. This is done for the reason that some conventional electricalimplantees cannot utilize more than eight (8) channels due to electricalspread through the conductive fluid and tissue in the cochlea. Opticalstimulation does not suffer this “spreading” problem and therefore hasan advantage in its ability to stimulate in a more specific andfine-grained manner, which leads to higher spectral fidelity for theimplantee. One challenge, however, is heating of the tissue by theoptical channels (particularly when activating many channels that areclose in space and/or that are activated close in time). Because thephysiological mechanism for stimulation using optical signals is thermal(i.e., heat is needed to trigger the desired CNAPs, careful engineeringis needed to allay thermal buildup in the cochlea. In some embodimentsof the present invention, signal coding strategies are used to reducethe number of channels active within a predetermined amount of time andwithin a given volume of tissue, therefore controlling (limiting amaximum amount of) the average power delivered and heat produced. Insome embodiments, an N-of-M coding strategy is used for the opticalstimulation of the cochlea (or other neural tissue) that is differentthan those used for electrical stimulation. In some embodiments, theoptical N-of-M coding place a quota on the number of and spacing offrequency channels selected to illuminate tissue during each time frame.Speech tends to fill the frequency spectrum between 50-6000 Hz andcochlear-implant speech processors tend to cover the range 240-6000 Hz,depending on insertion depth. In some embodiments, the present inventionbreaks this range into 22 (or other suitable total number)frequency-based channels and limits the optical stimulation generated toilluminate a maximum of 11 (or other suitable subset number) at eachtime-frame cycle. In some embodiments, the total number offrequency-based channels is divided into a plurality ofadjacent-frequency-based “bins,” wherein each bin corresponds to one ormore optical emitters within the cochlea that are close to one anotherin space (and thus each bin corresponds to a subset of adjacentfrequencies within the spectrum of audio frequencies used by the audioprocessor. In some embodiments, rather than simply activating the 11highest-power channels, some embodiments use a quota to illuminate atleast X channels from each bin of channels for a plurality of bins(e.g., in some embodiments, depending on the frequency content andloudness of the sounds received by the microphone the number of binshaving this minimum number of channels activated may vary) and no morethan Y channels from any one bin. This limits the number of activatedchannels (adjacent illuminated areas) per unit length (or volume, insome embodiments) of cochlea and therefore prevents localizedoverheating of the cochlea and reduces power consumption of the device.

Optimization of Individual Performance of an Optical Cochlear Implant

When a patient is implanted with a cochlear implant, the implant remainsoff for a period of time while the patient's body adapts to the implant.The patient then visits an audiologist to initiate use of the device andset parameters for best operation in the individual.

In some embodiments, a plurality of parameters is specified by thecomputer program used to implement the optimization of the presentinvention, or specified to the program by the audiologist (or patient)utilizing the program, as potential mechanisms for optimizing implantperformance for the individual patient. In some embodiments, thefollowing parameters are used to encode information on the opticalsignal: pulse width, peak power, stimulation rate, wavelength,polarization, wavelength profile, beam profile, beam angle.

In some embodiments, the following parameters are used to optimize theimplant performance during tuning of the device after implantation:pulse width, amplitude, frequency, wavelength, polarization, wavelengthprofile, beam profile, beam angle, coding strategy (e.g., N-of-M),signal-processing filter bandwidths, signal-processing filter shapes,signal-processing filter center frequencies, and operational/functioningchannels. Individual patients may find a range of comfort levels andsettings that provide best performance of the device for each one of aplurality of different listening environments (driving a car, voiceconversations, music listening and the like). In some embodiments, theaudiologist adjusts the above parameters to provide the patient withbest performance. In some embodiments, best performance is judged byspeech recognition, loudness comfort levels, physical comfort, and/ordevice battery life between rechargings of the battery.

In some embodiments, the present invention provides an apparatus andmethod in which an audiologist's console computer when acochlea-stimulation device is implanted into a patient, the implant isprogrammed to remain off for a period of time while the patient's bodyadapts to the implant. The patient then visits an audiologist toinitiate use of the device and set parameters for best operation in theindividual. The audiologist's console computer is programmed to providethe capability to customize operation of the implanted device whilepreventing programming of combinations of device operations that couldbe harmful to the patient or the device. The present invention providesmany parameters that are individually settable by the customizationprogram as potential mechanisms for optimizing implant performance forthe individual patient. In some embodiments, one or more of thefollowing parameters can be used to encode information on the opticalsignal: pulse width, peak power, intensity profile over time,stimulation rate, wavelength, polarization, wavelength profile (as afunction of spatial location, tissue type, recent-past history ofstimulation in a given area, and the like), beam spatial intensityprofile, beam angle and the like. In some embodiments, the followingparameters can be used to optimize the implant's performance duringtuning of the device after implantation: pulse width, amplitude,frequency, wavelength, polarization, wavelength profile, beam profile,beam angle, coding strategy (i.e., N-of-M), signal-processing filterbandwidths, signal-processing filter shapes,audio-signal-processing-filter center frequencies, selection ofoperational and/or best-functioning channels, and the like. Individualpatients may empirically determine a range of comfort levels andsettings that provide best performance of the device. The audiologistmay adjust the above parameters to provide the patient with bestperformance. In some embodiments, the patient is provided with a programthat they may take home and run on any suitable personal computer,wherein the program is configured to have the computer audibly output aset of calibration tones, tunes, speech or other sounds and to elicitand receive input indications from the patient, and to analyze thatinput to calculate parameters to be used by the implanted device (and/orthe externally-worn device having one or more microphones, power, andsound-processing capability). In some embodiments, “best” performancemay be judged by speech recognition, loudness comfort levels, physicalcomfort, and device battery life.

In some embodiments, the pulse-repetition rate is customized andoptimized for the individual during system tuning after implantation. Insome embodiments, the peak power of the light signal is customized andoptimized for the individual during system tuning after implantation.

In some embodiments, a set of optimal values for pulse-repetition rate,peak power and range of pulse width is determined for each of a numberof specific listening environments and sound sources of interest. Forexample, one set of parameters is optimized for listening to a malevoice in a quiet environment. Another set of parameters is optimized forlistening to a male voice in a noisy environment (e.g., a crowded room).A third set of parameters is optimized for listening to a female voicein a noisy environment (e.g., a crowded room). Listening environmentsinclude, but are not limited to, quiet, many other voices (e.g., a roomcrowded with people), road noise (e.g., riding in a car or othervehicle), and street noise (e.g., walking along a busy street).Exemplary sound-source environments include, but are not limited to,male or female voice conversations, music, and sounds of nature (e.g.,bird calls while bird watching).

In some embodiments, the user of the cochlear implant selects the set ofoperating parameters (pulse-repetition rate, peak power and pulse widthrange) to use at any point in time. The selection is made using a deviceexternal to the cochlear implant. In some embodiments, the externaldevice is included with an external sound-receiving andsignal-processing element that drives the cochlear implant. In otherembodiments, a separate device is used that is coupled to thecochlear-implant controller magnetically, via radio frequency signals,via light signals, or via other means. In some embodiments, thecontroller for the cochlear implant makes an operating-parameterselection based on the controller's analysis of the listeningenvironment. In some embodiments, a collection of sets of operatingparameters is provided by the manufacturer of the cochlear implant. Insome embodiments, a collection of sets of operating parameters isprovided by the audiologist or physician implanting the cochlearimplant. In some embodiments, a collection of sets of operatingparameters is determined by empirically testing the responses of thewearer of the cochlear implant. In some embodiments, some combination ofsources is used to determine the collection of available sets ofoperating parameters.

Encoding Information in an Optical Cochlear Implant UsingOptical-Pulse-Width Modulation

Experiments (see Izzo et al.: “Optical Parameter Variability in LaserNerve Stimulation: a study of pulse duration, repetition rate, andwavelength,” 2006; later published in IEEE Trans Biomed Eng. 2007 June;54(6 Pt 1):1108-14) have shown that neural compound action potentials(CAPs) can be evoked by pulsed optical stimulation and the magnitude ofthe action potential is a function of the peak power of the incidentpulses for pulses shorter than approximately 100 microseconds (μs). Aspulses are shortened and peak power is held constant, the CAP reduces.In some embodiments, this effect is utilized to encode loudnessinformation, as the CAP level determines perceived loudness.

In some embodiments, pulse-repetition rate and peak power are heldconstant, while pulse width is modulated to evoke a sufficient range ofCAPs, encoding sound information for the listener. An advantage of thismethod of encoding is the CAP can be very sensitive to pulse width inthis regime, and therefore pulse width is a useful parameter to achievea large range of stimulation for a small change in pulse width. In oneembodiment, the pulse width is customized and optimized for theindividual during system tuning after implantation.

In some embodiments, an optimal range of pulse widths is determined (insome such embodiments, the intensity may or may not vary). In someembodiments, the temporal shape of pulses is optimized. In someembodiments, different emitters are used for different portions ofpulse.

In some embodiments, the present invention provides an apparatus andmethod in which pulse-width modulation is applied to theoptical-stimulation pulses to the cochlea nerves to obtain an increaseddynamic range (a variation in the loudness perceived by the patient).Experiments (Izzo, 2006) have shown that neural compound nerve-actionpotentials (CNAPs, also called CAPs) can be evoked by pulsed opticalstimulation and the magnitude of the action potential is a function ofthe peak power of the incident pulses for pulses shorter than about 100microseconds (μs). As pulses are shortened and peak power is heldconstant, the CAP reduces. This effect can be utilized to encodeloudness information, since the CAP level determines perceived loudness.In some embodiments of the present invention, pulse-repetition rate andpeak pulse power are held constant, while pulse width is modulated toevoke a sufficient dynamic range of CAPs (i.e., different CAPstrengths), thus encoding sound-loudness information for the listener.An advantage of this method of encoding is the CAP can be very sensitiveto pulse width in this regime, and therefore optical-pulse width is auseful parameter to vary, and this achieves a large range of stimulationfor a small change in pulse width. In some embodiment, the pulse widthis adjusted to be optimized for the individual during successivesystem-tuning sessions after implantation.

Using a Broad Wavelength Profile to Homogenize the Absorption Profile inOptical Stimulation of Nerves

In some embodiments, the present invention provides an apparatus andmethod in which the power-versus-wavelength spectrum of the opticalstimulation light is customized to achieve a desired spatial-absorptionpattern. In electrical stimulation, one challenging problem is theundesired spreading of the electrical signal through the conductivefluid and tissue in the cochlea. The optical stimulation of the presentinvention does not suffer this problem and therefore has an advantage inits ability to stimulate in a more specific manner (i.e., to triggerCNAPs for narrower audio frequency ranges (more specific frequencies),for an increased number of different audio frequency ranges (thenarrower and more numerous audio frequency ranges result from theoptical stimulation that does not spread to adjacent tissues as much aselectrical stimulation does), and for a greater range of differentloudness levels (increased dynamic range), which leads to higherspectral fidelity for the implantee. A challenge that the presentinvention solves is to deliver a stimulation signal that triggers CNAPsthat are perceived as quite different loudnesses, i.e., as sounds with asubstantial dynamic range. The physical extent (the volume) of thestimulated region is limited by the absorption profile of the spiralganglion cells (or other suitable tissue cells) that are beingstimulated, and by the fluence of the optical spot at the tissueinterface. The absorption coefficient is wavelength dependent andtherefore the spatial absorption profile is wavelength dependent. When aspot of light illuminates the modiolus and reaches thespiral-ganglion-cell interface, the cells absorb light according totheir optical absorption coefficient. Because the light experiencesexponential decay as it travels through the volume of cells, theabsorption profile in the illuminated volume is exponential in nature,and more light is absorbed near the surface and less is absorbed deeperin the tissue (see FIG. 4, FIG. 4A, FIG. 4B, FIG. 4C, FIG. 4D, and FIG.4E).

FIG. 4 is a color-coded plot of a temperature profile of tissue due toabsorption of single-wavelength source of infrared light. When a singlewavelength is used to stimulate (as in FIG. 4, FIG. 4A, FIG. 4B, andFIG. 4C), there exists a limited range of fluence that can be utilizedfor stimulation. There is a minimum fluence to reach the hearingthreshold and, as the fluence is increased, deeper cells are recruitedfor stimulation but a limitation is reached when the interface tissue,where the bulk of the absorption is taking place, becomes too hot. Theexponential profile of absorption is unwanted if a large dynamic rangeis desired, which is the case in some embodiments of the presentinvention. In some embodiments, a broad linewidth source (e.g., see FIG.3A, FIG. 3C, and FIG. 3E) is used with an optimized wavelength profilethat homogenizes the absorption profile in the tissue. In oneembodiment, the profile may dynamically change as the power isincreased, optimizing the absorption profile. One advantage of thissolution is that the dynamic range is extended due to the even spread ofabsorption in the illuminated volume. As shown in FIG. 3A, FIG. 3C, FIG.3E, FIG. 4D, and FIG. 4E, in some embodiments, a broad wavelength sourceis used with a power/wavelength profile that is designed and crafted tohomogenize the absorption in the tissue. As shown in FIG. 4F, FIG. 4Gand FIG. 4H, in some embodiments, the wavelength source has apower/wavelength profile that is designed and crafted to change overtime such that the absorption in the tissue is customized to obtain thedesired triggering of NAPs.

In some embodiments, the first predetermined amount of energy is thesame as the second predetermined amount of energy, but the power of oneis increased and the duration is decreased by a compensating value suchthat even though the amounts of energy are the same, the peak powers aredifferent. In some embodiments, this is the result of using differentpulse shapes, wherein pulse shape is defined as the amount of power as afunction of time.

In some embodiments, the first pulsed optical-stimulation signal has afirst pulse at the first wavelength that starts at a first startingpoint in time and a second pulse at the second wavelength that starts ata second starting point in time, and wherein the first starting point ofthe signal at the first wavelength is different than the second startingpoint of the signal at the second wavelength and both the first andsecond pulses contribute to triggering the same NAP or CNAP (i.e., asingle NAP or a single CNAP). In other embodiments, the first pulsedoptical-stimulation signal has a first pulse at the first wavelengththat ends at a first ending point in time and a second pulse at thesecond wavelength that ends at a second ending point in time, andwherein the first ending point of the signal at the first wavelength isdifferent than the second ending point of the signal at the secondwavelength, and both the first and second pulses contribute totriggering the same NAP or CNAP. In either case, the pulses are notsimultaneous, but they are partially overlapped, or at least nearby intime so as to be synergistic in triggering one NAP or CNAP.

Further Discussion of Encoding Information in an Optical CochlearImplant Using Optical-Pulse-Width Modulation

In some embodiments, the present invention includes a method thatincludes generating a plurality of pulsed light signals having one ormore successive pulses that, when applied to a neuron of a person, willeach stimulate a nerve action potential (NAP) in the neuron, deliveringthe plurality of light signals to a plurality of locations in thecochlea of the person, and selectively controlling the plurality oflight signals to optically stimulate one or more neurons in the cochleain order to trigger NAPS in the one or more neurons of the cochlea. Theselectively controlling includes holding a pulse-repetition rate and apeak power of the plurality of light signals at a substantially constantvalue while empirically testing the delivering of the plurality of lightsignals and determining one or more values of pulse width of theplurality of light signals that is/are most effective for opticallystimulating the one or more neurons in the cochlea, and using theresults of the testing such that the delivering includes deliveringlight signals having pulse-width values that were determined to be mosteffective for optically stimulating.

For each of the embodiments described herein that determine of one ormore values that is/are most effective, other embodiments determine aplurality of values that are relatively more effective than othervalues. Thus, values determined to be not effective at all are not used,but other values have a range of effectiveness, and some embodiments useadditional factors (such as prevention of localized heating) to decidewhich values of the various parameters to use at each particular time.

In some embodiments, the selectively controlling includes determiningone or more ranges of pulse width of the plurality of light signals thatis/are most effective for optically stimulating the one or more neuronsin the cochlea. In some embodiments, the selectively controllingincludes determining one or more temporal shapes (i.e., light intensityas a function of time in each pulse or group of pulses) of pulses of theplurality of light signals that is/are most effective for opticallystimulating the one or more neurons in the cochlea. In some embodiments,a most-effective pulse width is no more than approximately 100microseconds.

In some embodiments, the selectively controlling includes determining alight-signal-coding strategy that is most effective for opticallystimulating the one or more neurons of the cochlea. In some embodiments,the selectively controlling further includes determining one or moresignal-processing-filter-bandwidth values that is/are most effective foroptically stimulating the one or more neurons of the cochlea.

In some embodiments, the present invention includes a method foroptically stimulating neurons of a cochlea of a person to providesound-perception auditory sensations for the person. The method includesgenerating a plurality of pulsed light signals having one or moresuccessive pulses that, when applied to a neuron of a person, will eachstimulate a nerve action potential (NAP) in the neuron, delivering theplurality of light signals to a plurality of locations in the cochlea ofthe person, and selectively controlling the plurality of light signalsto optically stimulate one or more neurons in the cochlea in order totrigger NAPS in the one or more neurons of the cochlea, where theselectively controlling includes holding a pulse-repetition rate and apeak power of the plurality of light signals at a substantially constantvalue and varying pulse-width values of the light signals. The variedpulse-width values cause the person to perceive different sound levels.

In some embodiments, the selectively controlling includes empiricallytesting the delivering of the plurality of light signals and determiningone or more values of pulse width of the plurality of light signals thatis/are most effective for optically stimulating the one or more neuronsin the cochlea, and using results of the testing such that thedelivering includes delivering light signals having pulse-width valuesthat were determined to be most effective for optically stimulating. Inother embodiments, the selectively controlling includes empiricallytesting the delivering of the plurality of light signals and determiningone or more light-signal-pulse-repetition rate and one or more peakpower of the plurality of light signals that is/are most effective foroptically stimulating the one or more neurons of the cochlea.

In some embodiments, the selectively controlling includes determiningone or more ranges of pulse width of the plurality of light signals thatis/are most effective for optically stimulating the one or more neuronsin the cochlea. In some embodiments, the selectively controllingincludes determining one or more temporal shapes of pulses of theplurality of light signals that is/are most effective for opticallystimulating the one or more neurons in the cochlea. In some embodiments,a most-effective pulse width is no more than approximately 100microseconds.

In some embodiments, the selectively controlling includes determining alight-signal-coding strategy that is most effective for opticallystimulating the one or more neurons of the cochlea. In some embodiments,the selectively controlling includes determining one or moresignal-processing-filter-bandwidth values that is/are most effective foroptically stimulating the one or more neurons of the cochlea. In someembodiments, the selectively controlling includes determining one ormore light-signal-polarization values that is/are most effective foroptically stimulating the one or more neurons of the cochlea.

In some embodiments of the present invention, the method furtherincludes obtaining an audio signal having an audio spectrum, determiningwhether the audio signal is spoken human voice or music, selecting afirst pulse-repetition rate, a first a peak power of the plurality oflight signals and a first pulse width range to improve voice perceptionin the person when the audio signal is spoken human voice, and selectinga second pulse-repetition rate, a second peak power of the plurality oflight signals and a second pulse width range to improve music perceptionin the person when the audio signal is music.

In some embodiments, the present invention includes an apparatus foroptically stimulating neurons of a cochlea of a person to providesound-perception auditory sensations for the person. The apparatusincludes a means for generating a plurality of pulsed light signalshaving one or more successive pulses that, when applied to a neuron of aperson, will each stimulate a nerve action potential (NAP) in theneuron, a means for delivering the plurality of light signals to aplurality of locations in the cochlea of the person, and a means forselectively controlling the plurality of light signals to opticallystimulate one or more neurons in the cochlea in order to trigger NAPS inthe one or more neurons of the cochlea, and where the means forselectively controlling includes means for holding a pulse-repetitionrate at a substantially constant value and a peak power of the pluralityof light signals at a substantially constant value and for varyingpulse-width values of the light signals such that the varied pulse-widthvalues cause the person to perceive a plurality of different soundlevels that correspond to the various sound-level content of receivedaudio signals.

In some embodiments, the means for selectively controlling includesmeans for empirically testing the delivering of the plurality of lightsignals and means for determining one or more values of pulse width ofthe plurality of light signals that is/are most effective for opticalstimulation of the one or more neurons in the cochlea, and means forusing results from the means for testing such that the delivery includeslight signals having pulse-width values that were determined to be mosteffective for optical stimulation. In some embodiments, the means forselectively controlling includes means for empirically testing thedelivery of the plurality of light signals and means for determining oneor more light-signal-pulse-repetition rates and one or more peak powervalues of the plurality of light signals that are most effective foroptical stimulation of the one or more neurons of the cochlea. In someembodiments, the means for selectively controlling includes means fordetermining one or more ranges of pulse width of the plurality of lightsignals that is/are most effective for optical stimulation of the one ormore neurons in the cochlea. In other embodiments, the means forselectively controlling includes means for determining one or moretemporal shapes (i.e., light intensity as a function of time in eachpulse or group of pulses) of pulses of the plurality of light signalsthat is/are most effective for optical stimulation of the one or moreneurons in the cochlea. In some embodiments, a most-effective pulsewidth is no more than approximately 100 microseconds.

In some embodiments, the means for selectively controlling includesmeans for determining a light-signal-coding strategy that is mosteffective for optical stimulation of the one or more neurons of thecochlea. In some embodiments, the means for selectively controllingincludes means for determining one or moresignal-processing-filter-bandwidth values that is/are most effective foroptical stimulation of the one or more neurons of the cochlea. In someembodiments, the means for selectively controlling includes means fordetermining one or more light-signal-polarization values that is/aremost effective for optical stimulation of the one or more neurons of thecochlea.

In some embodiments, the present invention further includes a means forobtaining an audio signal having an audio spectrum, a means fordetermining whether the audio signal is spoken human voice or music, ameans for selecting a first pulse-repetition rate, a first a peak powerof the plurality of light signals and a first pulse-width range toimprove voice perception in the person when the audio signal is spokenhuman voice, and a means for selecting a second pulse-repetition rate, asecond peak power of the plurality of light signals and a secondpulse-width range to improve music perception in the person when theaudio signal is music.

In some embodiments, the present invention includes an apparatus foroptically stimulating neurons of a cochlea of a person to providesound-perception auditory sensations for the person. The apparatusincludes an optical generator configured to output a plurality of pulsedlight signals that each have one or more successive pulses that, whenapplied to a neuron of a person, will each stimulate a nerve actionpotential (NAP) in the neuron, an optical guide configured to deliverthe plurality of light signals to a plurality of locations in thecochlea of the person, and a controller configured to selectivelycontrol the plurality of light signals to optically stimulate one ormore neurons in the cochlea in order to trigger NAPs in the one or moreneurons of the cochlea. A pulse-repetition rate and a peak power of theplurality of light signals are held at a substantially constant valueand pulse-width values of the light signals are varied, such that thevaried pulse-width values cause the person to perceive different soundlevels.

In some embodiments, the controller is configured to empirically testthe delivery of the plurality of light signals, to determine one or morevalues of pulse width of the plurality of light signals that is/are mosteffective for optical stimulation of the one or more neurons in thecochlea, and to use results of the test such that the delivered lightsignals have pulse-width values that were determined to be mosteffective for optical stimulation. In other embodiments, the controlleris further configured to empirically test the delivery of the pluralityof light signals and to determine one or morelight-signal-pulse-repetition rate and one or more peak power of theplurality of light signals that are most effective for opticalstimulation of the one or more neurons of the cochlea. In someembodiments, the controller is further configured to determine one ormore ranges of pulse width of the plurality of light signals that is/aremost effective for optical stimulation of the one or more neurons in thecochlea. In other embodiments, the controller is configured to determineone or more temporal shapes of pulses of the plurality of light signalsthat is/are most effective for optical stimulation of the one or moreneurons in the cochlea. In some embodiments, a most-effective pulsewidth is no more than approximately 100 microseconds.

In some embodiments, the controller is configured to determine alight-signal-coding strategy that is most effective for opticalstimulation of the one or more neurons of the cochlea. In someembodiments, the controller is configured to determine one or moresignal-processing-filter-bandwidth values that is/are most effective foroptical stimulation of the one or more neurons of the cochlea. In someembodiments, the controller is configured to determine one or morelight-signal-polarization values that is/are most effective for opticalstimulation of the one or more neurons of the cochlea.

In some embodiments, the present invention includes an audio sensorconfigured to obtain an audio signal that has an audio spectrum, and anaudio processor configured to determine whether the audio signal isspoken human voice or music, select a first pulse-repetition rate, afirst a peak power of the plurality of light signals and a firstpulse-width range to improve voice perception in the person when theaudio signal is spoken human voice, and select a second pulse-repetitionrate, a second peak power of the plurality of light signals and a secondpulse-width range to improve music perception in the person when theaudio signal is music.

The present invention, in some embodiments, includes a non-transitorycomputer readable medium having instructions stored thereon for causinga suitably programmed information processor to perform a method foroptically stimulating neurons of a cochlea of a person to providesound-perception auditory sensations for the person. The method includesgenerating a plurality of pulsed light signals having one or moresuccessive pulses that, when applied to a neuron of a person, will eachstimulate a nerve action potential (NAP) in the neuron, delivering theplurality of light signals to a plurality of locations in the cochlea ofthe person, selectively controlling the plurality of light signals tooptically stimulate one or more neurons in the cochlea in order totrigger NAPs in the one or more neurons of the cochlea. The selectivelycontrolling includes holding a pulse-repetition rate and a peak power ofthe plurality of light signals at a substantially constant value andvarying pulse-width values of the light signals such that the variedpulse-width values cause the person to perceive different sound levels.

In some embodiments, the non-transitory computer readable medium furtherincludes instructions such that the selectively controlling includesempirically testing the delivering of the plurality of light signals anddetermining one or more values of pulse width of the plurality of lightsignals that is/are most effective for optically stimulating the one ormore neurons in the cochlea, and using results of the testing such thatthe delivering includes delivering light signals having pulse-widthvalues that were determined to be most effective for opticallystimulating. In some embodiments, the non-transitory computer readablemedium further includes instructions such that the selectivelycontrolling includes empirically testing the delivering of the pluralityof light signals and determining one or morelight-signal-pulse-repetition rates and one or more peak power values ofthe plurality of light signals that are most effective for opticallystimulating the one or more neurons of the cochlea.

In some embodiments, the non-transitory computer readable medium furtherincludes instructions such that the selectively controlling includesdetermining one or more ranges of pulse width of the plurality of lightsignals that is/are most effective for optically stimulating the one ormore neurons in the cochlea. In some embodiments, the non-transitorycomputer readable medium further includes instructions such that theselectively controlling includes determining one or more temporal shapes(i.e., light intensity as a function of time in each pulse or group ofpulses) of pulses of the plurality of light signals that is/are mosteffective for optically stimulating the one or more neurons in thecochlea. In some embodiments, the non-transitory computer readablemedium further includes instructions such that a most-effective pulsewidth is no more than approximately 100 microseconds.

In some embodiments, the non-transitory computer readable medium furtherincludes instructions such that the selectively controlling includesdetermining a light-signal-coding strategy that is most effective foroptically stimulating the one or more neurons of the cochlea. In someembodiments, the non-transitory computer readable medium furtherincludes instructions such that the selectively controlling includesdetermining one or more audio-signal-processing-filter-bandwidth valuesthat is/are most effective (or those that are relatively more effectivethan other audio-signal-processing-filter-bandwidth values) foroptically stimulating the one or more neurons of the cochlea. In someembodiments, the non-transitory computer readable medium furtherincludes instructions such that the selectively controlling includesdetermining one or more light-signal-polarization values that is/aremost effective for optically stimulating the one or more neurons of thecochlea.

In some embodiments of the present invention, the non-transitorycomputer readable medium includes instructions such that the methodfurther includes obtaining an audio signal having an audio spectrum,determining whether the audio signal is spoken human voice or music,selecting a first pulse-repetition rate, a first a peak power of theplurality of light signals and a first pulse width range to improvevoice perception in the person when the audio signal is spoken humanvoice, and selecting a second pulse-repetition rate, a second peak powerof the plurality of light signals and a second pulse width range toimprove music perception in the person when the audio signal is music.

It is specifically contemplated that the present invention includesembodiments having combinations and subcombinations of the variousembodiments and features that are individually described herein and inpatents and applications incorporated herein by reference (i.e., ratherthan listing every combinatorial of the elements, this specificationincludes descriptions of representative embodiments and contemplatesembodiments that include some of the features from one embodimentcombined with some of the features of another embodiment). Further, someembodiments include fewer than all the components described as part ofany one of the embodiments described herein.

It is to be understood that the above description is intended to beillustrative, and not restrictive. Although numerous characteristics andadvantages of various embodiments as described herein have been setforth in the foregoing description, together with details of thestructure and function of various embodiments, many other embodimentsand changes to details will be apparent to those of skill in the artupon reviewing the above description. The scope of the invention shouldbe, therefore, determined with reference to the appended claims, alongwith the full scope of equivalents to which such claims are entitled. Inthe appended claims, the terms “including” and “in which” are used asthe plain-English equivalents of the respective terms “comprising” and“wherein,” respectively. Moreover, the terms “first,” “second,” and“third,” etc., are used merely as labels, and are not intended to imposenumerical requirements on their objects.

1. A method for optically stimulating neurons of a cochlea of a personto provide sound-perception auditory sensations for the person, themethod comprising: generating a plurality of pulsed light signals havingone or more successive pulses that, when applied to a neuron of aperson, will each stimulate a nerve action potential (NAP) in theneuron; delivering the plurality of light signals to a plurality oflocations in the cochlea of the person; and selectively controlling theplurality of light signals to optically stimulate one or more neurons inthe cochlea in order to trigger NAPs in the one or more neurons of thecochlea, wherein the selectively controlling includes holding apulse-repetition rate and a peak power of the plurality of light signalsat a substantially constant value and varying pulse-width values of thelight signals to cause the person to perceive different sound levels. 2.The method of claim 1, wherein the selectively controlling includesempirically testing the delivering of the plurality of light signals anddetermining one or more values of pulse width of the plurality of lightsignals that is most effective for optically stimulating the one or moreneurons in the cochlea, and using results of the testing such that thedelivering includes delivering light signals having pulse-width valuesthat were determined to be most effective for optically stimulating theone or more neurons in the cochlea to cause the person to perceivedifferent sound levels.
 3. The method of claim 1, wherein theselectively controlling includes empirically testing the delivering ofthe plurality of light signals and determining one or morelight-signal-pulse-repetition rates and one or more peak power values ofthe plurality of light signals that are most effective for opticallystimulating the one or more neurons of the cochlea to cause the personto perceive different sound levels.
 4. The method of claim 1, whereinthe selectively controlling includes determining one or more ranges ofpulse width of the plurality of light signals that is most effective foroptically stimulating the one or more neurons in the cochlea.
 5. Themethod of claim 1, wherein the selectively controlling includesdetermining one or more temporal shapes of pulses of the plurality oflight signals that is most effective for optically stimulating the oneor more neurons in the cochlea.
 6. The method of claim 1, wherein amost-effective pulse width is no more than approximately 100microseconds.
 7. The method of claim 1, further comprising: obtaining anaudio signal having an audio spectrum; determining whether the audiosignal is spoken human voice or music; selecting a firstpulse-repetition rate, a first a peak power of the plurality of lightsignals and a first pulse width range to improve voice perception in theperson when the audio signal is spoken human voice; and selecting asecond pulse-repetition rate, a second peak power of the plurality oflight signals and a second pulse width range to improve music perceptionin the person when the audio signal is music.
 8. An apparatus foroptically stimulating neurons of a cochlea of a person to providesound-perception auditory sensations for the person, the apparatuscomprising: means for generating a plurality of pulsed light signalseach having a plurality of successive pulses that, when applied to aneuron of a person, will each stimulate a nerve action potential (NAP)in the neuron; means for delivering the plurality of light signals to aplurality of locations in the cochlea of the person; and means forselectively controlling the plurality of light signals to opticallystimulate one or more neurons in the cochlea in order to trigger NAPs inthe one or more neurons of the cochlea, wherein the means forselectively controlling includes means for holding a pulse-repetitionrate and a peak power of the plurality of light signals at asubstantially constant value and means for varying pulse-width values ofthe light signals wherein the varied pulse-width values cause the personto perceive different sound levels.
 9. The apparatus of claim 8, whereinthe means for selectively controlling includes means for empiricallytesting the delivery of the plurality of light signals and means fordetermining one or more values of pulse width of the plurality of lightsignals that is most effective for optically stimulating the one or moreneurons in the cochlea, and means for using results from the means fortesting to control the means for delivering to deliver light signalshaving pulse-width values that were determined to be most effective foroptically stimulating.
 10. The apparatus of claim 8, wherein the meansfor selectively controlling includes means for empirically testing thedelivering of the plurality of light signals and means for determiningone or more light-signal-pulse-repetition rates and one or more peakpower values of the plurality of light signals that are most effectivefor optically stimulating the one or more neurons of the cochlea. 11.The apparatus of claim 8, wherein the means for selectively controllingincludes means for determining one or more ranges of pulse width of theplurality of light signals that is most effective for opticallystimulating the one or more neurons in the cochlea.
 12. The apparatus ofclaim 8, wherein the means for selectively controlling includes meansfor determining one or more temporal shapes of pulses of the pluralityof light signals that is most effective for optically stimulating theone or more neurons in the cochlea.
 13. The apparatus of claim 8,wherein a most-effective pulse width is no more than approximately 100microseconds.
 14. The apparatus of claim 8, further comprising: meansfor obtaining an audio signal having an audio spectrum; means fordetermining whether the audio signal is spoken human voice or music;means for selecting a first pulse-repetition rate, a first a peak powerof the plurality of light signals and a first pulse-width range toimprove voice perception in the person when the audio signal is spokenhuman voice; and means for selecting a second pulse-repetition rate, asecond peak power of the plurality of light signals and a secondpulse-width range to improve music perception in the person when theaudio signal is music.
 15. An apparatus for optically stimulatingneurons of a cochlea of a person to provide sound-perception auditorysensations for the person, the apparatus comprising: an opticalgenerator configured to output a plurality of pulsed light signalshaving one or more successive pulses that, when applied to a neuron of aperson, will each stimulate a nerve action potential (NAP) in theneuron; an optical guide configured to deliver the plurality of lightsignals to a plurality of locations in the cochlea of the person; and acontroller configured to selectively control the plurality of lightsignals to optically stimulate one or more neurons in the cochlea inorder to trigger NAPS in the one or more neurons of the cochlea, whereina pulse-repetition rate and a peak power of the plurality of lightsignals are held at a substantially constant value and pulse-widthvalues of the light signals are varied, wherein the varied pulse-widthvalues cause the person to perceive different sound levels.
 16. Theapparatus of claim 15, wherein the controller is further configured toempirically test the delivery of the plurality of light signals todetermine one or more values of pulse width of the plurality of lightsignals that is most effective for optically stimulating the one or moreneurons in the cochlea, and to use results of the test such that thedelivered light signals have pulse-width values that were determined tobe most effective for optically stimulating.
 17. The apparatus of claim15, wherein the controller is further configured to empirically test thedelivery of the plurality of light signals and to determine one or morelight-signal-pulse-repetition rates and one or more peak power values ofthe plurality of light signals that are most effective for opticallystimulating the one or more neurons of the cochlea.
 18. The apparatus ofclaim 15, wherein the controller is further configured to determine oneor more ranges of pulse width of the plurality of light signals that ismost effective for optically stimulating the one or more neurons in thecochlea.
 19. The apparatus of claim 15, wherein the controller isfurther configured to determine one or more temporal shapes of pulses ofthe plurality of light signals that is most effective for opticallystimulating the one or more neurons in the cochlea.
 20. The apparatus ofclaim 15, further comprising: an audio sensor configured to obtain anaudio signal having an audio spectrum; and an audio processor configuredto: determine whether the audio signal is spoken human voice or music,select a first pulse-repetition rate, a first a peak power of theplurality of light signals and a first pulse-width range to improvevoice perception in the person when the audio signal is spoken humanvoice, and select a second pulse-repetition rate, a second peak power ofthe plurality of light signals and a second pulse-width range to improvemusic perception in the person when the audio signal is music.